Fresh Recalls

FDAClass I · Medical device · Recall Z-3149-2026 · Recalled September 23, 2026

Impella Optical Controller with the below product descriptions and corresponding Product C recall — Abiomed, Inc.

Agency report date: September 23, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Impella Optical Controller with the below product descriptions and corresponding Product C
Company / brand
Abiomed
Lot / serial / date codes
1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131; 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092, IC9432, IC11485, IC12328, IC12329, IC12332, IC12334, IC12346, IC13037, IC13038, IC8714, IC8775, IC8812, IC9005A, IC9006A, IC9008, IC9093, IC9096, IC9299, IC9783, IC9784, IC9961, IC7231, IC5037, IC5038, IC11162, IC11498, IC12326, IC12984, IC13239, IC13797, IC8488, IC8494, IC8503, IC8514, IC8588, IC8589, IC8642, IC8646, IC11691, IC4946, IC4947, IC4948, IC4949, IC4950, IC4951, IC4952, IC4953, IC4954, IC4955, IC4957, IC4958, IC4959, IC4960, IC4961, IC5039, IC5040, IC5041, IC5044, IC5045, IC5076, IC5077, IC5078, IC5079, IC5080, IC5081, IC5082, IC5084, IC5085, IC5096, IC5097, IC5098, IC5099, IC5100, IC5101, IC5102, IC5103, IC5104, IC5105, IC5106, IC5107, IC5108, IC5109, IC5110, IC5111, IC5112, IC5113, IC5114, IC5115, IC5126, IC5127, IC5128, IC5132, IC5133, IC5134, IC5135, IC5136, IC5137, IC5138, IC5139, IC5140, IC5141, IC5142, IC5143, IC5144, IC5145, IC5156, IC5157, IC5158, IC5159, IC5160, IC5161, IC5162, IC5163, IC5164, IC5233, IC5234, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5281, IC5283, IC5284, IC5285, IC5350, IC5355, IC5376, IC5377, IC5378, IC5383, IC5396, IC5397, IC5399, IC5400, IC5401, IC5402, IC5403, IC5404, IC5407, IC5408, IC5410, IC5411, IC5412, IC5413, IC5414, IC5415, IC5526, IC5527, IC5528, IC5529, IC5530, IC5531, IC5532, IC5533, IC5534, IC5535, IC5566, IC5567, IC5568, IC5569, IC5570, IC5571, IC5572, IC5573, IC5574, IC5575, IC5576, IC5577, IC5578, IC5579, IC5581, IC5582, IC5583, IC5584, IC5585, IC5586, IC5587, IC5588, IC5589, IC5590, IC5591, IC5594, IC5595, IC5626, IC5627, IC5628, IC5629, IC5630, IC5631, IC5632, IC5633, IC5634, IC5635, IC5636, IC5638, IC5639, IC5640, IC5641, IC5642, IC5643, IC5644, IC5645, IC5666, IC5667, IC5668, IC5669, IC5671, IC5672, IC5801, IC5802, IC5803, IC5804, IC5805, IC5806, IC5807, IC5808, IC5809, IC5810, IC5811, IC5812, IC5813, IC5814, IC5896, IC5897, IC5898, IC5899, IC5900, IC5902, IC5903, IC5904, IC5905, IC5916, IC5918, IC5920, IC5921, IC5922, IC5923, IC5924, IC5925, IC5963, IC5964, IC5965, IC5966, IC5967, IC5968, IC6012, IC6013, IC6014, IC6015, IC6016, IC6017, IC6018, IC6019, IC6020, IC6021, IC6022, IC6023, IC6024, IC6025, IC6067, IC6068, IC6069, IC6070, IC6073, IC6074, IC6075, IC6116, IC6117, IC6120, IC6121, IC6122, IC6123, IC6124, IC6166, IC6167, IC6168, IC6169, IC6171, IC6172, IC6173, IC6174, IC6175, IC6226, IC6229, IC6230, IC6231, IC6232, IC6234, IC6235, IC6256, IC6257, IC6258, IC6259, IC6260, IC6265, IC6276, IC6278, IC6279, IC6280, IC6281, IC6282, IC6283, IC6297, IC6298, IC6299, IC6302, IC6303, IC6304, IC6305, IC6336, IC6337, IC6338, IC6339, IC6340, IC6341, IC6342, IC6343, IC6344, IC6345, IC6376, IC6377, IC6378, IC6379, IC6383, IC6384, IC6416, IC6417, IC6418, IC6421, IC6422, IC6460, IC6461, IC6462, IC6463, IC6465, IC6698, IC6703, IC6758, IC6776, IC6777, IC6779, IC6780, IC6781, IC6784, IC6785, IC6788, IC6789, IC6790, IC6791, IC6792, IC6793, IC6794, IC6795, IC6866, IC6867, IC6868, IC6869, IC6870, IC6871, IC6872, IC6873, IC6874, IC6875, IC6936, IC6937, IC6938, IC6939, IC6940, IC6941, IC6942, IC6943, IC6944, IC6945, IC6946, IC6949, IC6950, IC6951, IC6952, IC6954, IC6955, IC6986, IC6987, IC6988, IC7047, IC7048, IC7049, IC7050, IC7051, IC7052, IC7053, IC7054, IC7055, IC7156, IC7157, IC7158, IC7159, IC7160, IC7161, IC7163, IC7164, IC7226, IC7227, IC7232, IC7233, IC7234, IC7235, IC7266, IC7267, IC7268, IC7269, IC7270, IC7271, IC7272, IC7273, IC7274, IC7275, IC7356, IC7357, IC7358, IC7359, IC7360, IC7361, IC7362, IC7363, IC7364, IC7457, IC7458, IC7459, IC7460, IC7461, IC7462, IC7463, IC7464, IC7465, IC7523, IC7524, IC7525, IC7526, IC7528, IC7586, IC7587, IC7588, IC7589, IC7590, IC7620, IC7621, IC7622, IC7623, IC7624, IC7626, IC7627, IC7628, IC7710, IC7711, IC7738, IC7739, IC7792, IC7793, IC7821, IC7822, IC7823, IC7824, IC7826, IC7829, IC7830, IC7860, IC7863, IC7864, IC7865, IC7866, IC7867, IC7868, IC7869, IC7920, IC7939, IC7943, IC7944, IC7947, IC7953, IC7956, IC7958, IC7964, IC7965, IC8011, IC8012, IC8059, IC8060, IC8061, IC8063, IC8067, IC8068, IC8071, IC8073, IC8074, IC8075, IC8117, IC8118, IC8119, IC8122, IC8123, IC8124, IC8125, IC8145, IC8146, IC8159, IC8160, IC8161, IC8165, IC8201, IC8202, IC8203, IC8204, IC8205, IC8206, IC8217, IC8218, IC8219, IC8220, IC8221, IC8226, IC8252, IC8253, IC8254, IC8255, IC8256, IC8257, IC8258, IC8259, IC8260, IC8261, IC8262, IC8336, IC8340, IC8342, IC8344, IC8345, IC8395, IC8396, IC8397, IC8400, IC8403, IC8405, IC8421, IC8422, IC8423, IC8424, IC8439, IC8443, IC8444, IC8450, IC8457, IC8482, IC8486, IC8487, IC8499, IC8511, IC8512, IC8584, IC8586, IC8591, IC8592, IC8600, IC8610, IC8622, IC8625, IC8639, IC8643, IC8644, IC8645, IC8647, IC8648, IC8649, IC8661, IC8662, IC8663, IC8664, IC8690, IC8691, IC8693, IC8696, IC8723, IC8725, IC8726, IC8729, IC8737, IC8739, IC8931, IC8338, IC8339, IC8596, IC8608, IC8655, IC8665, IC8692, IC8761, IC8762, IC8813, IC9349, IC9372, IC7827, IC7828, IC8133, IC8134, IC9385, IC8404, IC8420, IC11746, IC12327, IC12344, IC13040, IC8425, IC8426, IC8427, IC8428, IC7861, IC7862, IC7954, IC7957, IC8120, IC8121, IC8222, IC8225, IC9027, IC9090, IC9091, IC8062, IC8066, IC5042, IC5129, IC5282, IC5580, IC5919, IC6118, IC6119, IC6261, IC6263, IC6459, IC7456, IC7529, IC7797, IC7941, IC7942, IC7955, IC8147, IC8442, IC8495, IC8513, IC8590, IC8753, IC8754, IC8755, IC8764, IC8765, IC9085, IC9230, IC9367, IC8875, IC9383, IC9796, IC9866, IC9974, IC10023, IC10024, IC9996, IC9998, IC11491, IC11451, IC11456, IC11497, IC11500, IC11741, IC11742, IC11745, IC11747, IC11748, IC11749; 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN; UDI-DI: 00813502011425; Serial Numbers: IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8609, IC8980, IC9177, IC9178, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970; 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK; UDI-DI: 00813502010978; Serial Numbers: IC8105, IC8106, IC8308, IC8315, IC8316, IC8335, IC8541, IC8542, IC8543, IC8895, IC9163, IC10013, IC10014, IC11023, IC11183, IC11442, IC12507, IC9133, IC9443, IC10012, IC10015, IC10039, IC10044, IC10319, IC10320, IC10640, IC10641, IC10645, IC10646, IC10648, IC10649, IC11019, IC11026, IC11027, IC11028, IC11048, IC11071, IC11086, IC11190, IC11201, IC11202, IC11441, IC11444, IC11445, IC11448, IC12503, IC12504, IC12579, IC12580, IC12581, IC12582, IC12719, IC12720, IC12721, IC12723, IC13159, IC13201, IC13204, IC13219, IC13220, IC13221, IC13278, IC13279, IC13280, IC8334, IC8767, IC8768, IC8774, IC9441, IC9445, IC9599, IC10040, IC10043, IC10808, IC11186, IC11211, IC11440, IC12505, IC12506, IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC8113, IC8114, IC8115, IC8116, IC8127, IC8129, IC8297, IC8331, IC8332, IC8333, IC8561, IC8563, IC8593, IC8594, IC9442, IC9444, IC9447, IC9448, IC9450, IC8295; 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US; UDI-DI: 00813502010985; Serial Numbers: IC11685, IC5970, IC5971, IC6956, IC6957, IC6958, IC6959, IC6960, IC6961, IC6962, IC6963, IC6964, IC6965, IC6966, IC6967, IC6968, IC6969, IC6970, IC6971, IC6972, IC6973, IC6974, IC6975, IC6996, IC6997, IC6998, IC6999, IC7000, IC7001, IC7002, IC7003, IC7004, IC7005, IC7006, IC7007, IC7009, IC7011, IC7012, IC7013, IC7014, IC7015, IC7016, IC7017, IC7018, IC7019, IC7020, IC7021, IC7022, IC7023, IC7024, IC7025, IC7036, IC7037, IC7038, IC7109, IC7110, IC7111, IC7112, IC7113, IC7114, IC7115, IC7116, IC7117, IC7118, IC7119, IC7120, IC7123, IC7125, IC7127, IC7128, IC7129, IC7130, IC7131, IC7132, IC7135, IC7136, IC7137, IC7138, IC7139, IC7150, IC7151, IC7152, IC7153, IC7154, IC7155, IC7166, IC7167, IC7168, IC7169, IC7170, IC7171, IC7172, IC7173, IC7174, IC7175, IC7176, IC7177, IC7178, IC7179, IC7192, IC7193, IC7194, IC7195, IC7196, IC7197, IC7198, IC7199, IC7200, IC7201, IC7202, IC7203, IC7204, IC7205, IC7206, IC7208, IC7209, IC7210, IC7211, IC7212, IC7213, IC7214, IC7215, IC7216, IC7217, IC7222, IC7223, IC7224, IC7225, IC7236, IC7237, IC7238, IC7239, IC7240, IC7241, IC7243, IC7244, IC7245, IC7246, IC7247, IC7249, IC7250, IC7251, IC7252, IC7253, IC7254, IC7255, IC7276, IC7277, IC7278, IC7279, IC7280, IC7281, IC7282, IC7283, IC7284, IC7285, IC7296, IC7297, IC7298, IC7299, IC7300, IC7301, IC7302, IC7303, IC7304, IC7305, IC7306, IC7307, IC7308, IC7313, IC7315, IC7316, IC7317, IC7318, IC7319, IC7320, IC7321, IC7322, IC7324, IC7325, IC7326, IC7327, IC7328, IC7329, IC7330, IC7331, IC7332, IC7333, IC7334, IC7335, IC7336, IC7337, IC7338, IC7344, IC7345, IC7346, IC7347, IC7348, IC7349, IC7350, IC7351, IC7352, IC7353, IC7354, IC7355, IC7366, IC7367, IC7368, IC7369, IC7370, IC7371, IC7372, IC7373, IC7374, IC7375, IC7396, IC7397, IC7398, IC7399, IC7400, IC7401, IC7402, IC7403, IC7404, IC7405, IC7466, IC7467, IC7468, IC7469, IC7470, IC7471, IC7472, IC7473, IC7474, IC7476, IC7477, IC7478, IC7479, IC7480, IC7481, IC7482, IC7483, IC7484, IC7485, IC7486, IC7487, IC7488, IC7489, IC7490, IC7491, IC7492, IC7493, IC7494, IC7495, IC7496, IC7497, IC7498, IC7499, IC7500, IC7501, IC7502, IC7503, IC7504, IC7505, IC7506, IC7507, IC7508, IC7509, IC7510, IC7511, IC7512, IC7513, IC7514, IC7515, IC7516, IC7517, IC7518, IC7534, IC7535, IC7536, IC7537, IC7538, IC7539, IC7540, IC7541, IC7542, IC7543, IC7544, IC7545, IC7547, IC7548, IC7549, IC7550, IC7551, IC7552, IC7553, IC7554, IC7555, IC7556, IC7557, IC7558, IC7559, IC7561, IC7564, IC7570, IC7573, IC7574, IC7599, IC7600, IC7601, IC7602, IC7603, IC7604, IC7605, IC7616, IC7617, IC7618, IC7619, IC7658, IC7659, IC7660, IC7661, IC7662, IC7663, IC7664, IC7665, IC7676, IC7677, IC7678, IC7679, IC7699, IC7700, IC7701, IC7702, IC7703, IC7704, IC7705, IC7706, IC7707, IC7712, IC7713, IC7714, IC7715, IC7726, IC7727, IC7728, IC7729, IC7730, IC7731, IC7732, IC7733, IC7734, IC7735, IC7736, IC7737, IC7742, IC7743, IC7744, IC7745, IC7756, IC7757, IC7758, IC7759, IC7760, IC7761, IC7771, IC7772, IC7773, IC7774, IC7775, IC7786, IC7787, IC7788, IC7789, IC7790, IC7791, IC7802, IC7803, IC7804, IC7805, IC7816, IC7817, IC7818, IC7819, IC7820, IC7877, IC7878, IC7879, IC7880, IC7882, IC7883, IC7884, IC7890, IC7893, IC7894, IC7906, IC7908, IC7974, IC8002, IC8003, IC8004, IC8006, IC8008, IC8026, IC8029, IC8034, IC8035, IC8037, IC8040, IC8041, IC10049, IC10066, IC10587, IC9228, IC9229, IC9610, IC9622, IC9773, IC9780, IC9781, IC9782, IC10102, IC10103, IC10318, IC10463, IC10589, IC10979, IC11299, IC12316, IC12758, IC12859, IC12900, IC13812, IC9989, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC11656, IC11670, IC11674, IC11677, IC12214, IC12279, IC12414, IC12415, IC12417, IC12418, IC12419, IC12820, IC12857, IC12858, IC12870, IC12885, IC12973, IC12974, IC13231, IC13263, IC13264, IC13265, IC13268, IC13270, IC13271, IC13681, IC13682, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC7010, IC12884, IC12953, IC13232, IC13698, IC12968, IC13212, IC13269, IC13862;
Distribution
Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;
Agency product description and boundaries

Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class I: most serious — reasonable probability of serious health consequences or death.

Affected product: Impella Optical Controller with the below product descriptions and corresponding Product C recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-3149-2026
Brand
All Abiomed recalls
Classification
Class I
Units affected
1422 units (487 US, 935 OUS)
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Danvers, MA, United States
Firm address
22 Cherry Hill Dr, N/A, 01923-2575

Identifying details (verbatim from the notice)

Product codes / lots
1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131; 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092, IC9432, IC11485, IC12328, IC12329, IC12332, IC12334, IC12346, IC13037, IC13038, IC8714, IC8775, IC8812, IC9005A, IC9006A, IC9008, IC9093, IC9096, IC9299, IC9783, IC9784, IC9961, IC7231, IC5037, IC5038, IC11162, IC11498, IC12326, IC12984, IC13239, IC13797, IC8488, IC8494, IC8503, IC8514, IC8588, IC8589, IC8642, IC8646, IC11691, IC4946, IC4947, IC4948, IC4949, IC4950, IC4951, IC4952, IC4953, IC4954, IC4955, IC4957, IC4958, IC4959, IC4960, IC4961, IC5039, IC5040, IC5041, IC5044, IC5045, IC5076, IC5077, IC5078, IC5079, IC5080, IC5081, IC5082, IC5084, IC5085, IC5096, IC5097, IC5098, IC5099, IC5100, IC5101, IC5102, IC5103, IC5104, IC5105, IC5106, IC5107, IC5108, IC5109, IC5110, IC5111, IC5112, IC5113, IC5114, IC5115, IC5126, IC5127, IC5128, IC5132, IC5133, IC5134, IC5135, IC5136, IC5137, IC5138, IC5139, IC5140, IC5141, IC5142, IC5143, IC5144, IC5145, IC5156, IC5157, IC5158, IC5159, IC5160, IC5161, IC5162, IC5163, IC5164, IC5233, IC5234, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5281, IC5283, IC5284, IC5285, IC5350, IC5355, IC5376, IC5377, IC5378, IC5383, IC5396, IC5397, IC5399, IC5400, IC5401, IC5402, IC5403, IC5404, IC5407, IC5408, IC5410, IC5411, IC5412, IC5413, IC5414, IC5415, IC5526, IC5527, IC5528, IC5529, IC5530, IC5531, IC5532, IC5533, IC5534, IC5535, IC5566, IC5567, IC5568, IC5569, IC5570, IC5571, IC5572, IC5573, IC5574, IC5575, IC5576, IC5577, IC5578, IC5579, IC5581, IC5582, IC5583, IC5584, IC5585, IC5586, IC5587, IC5588, IC5589, IC5590, IC5591, IC5594, IC5595, IC5626, IC5627, IC5628, IC5629, IC5630, IC5631, IC5632, IC5633, IC5634, IC5635, IC5636, IC5638, IC5639, IC5640, IC5641, IC5642, IC5643, IC5644, IC5645, IC5666, IC5667, IC5668, IC5669, IC5671, IC5672, IC5801, IC5802, IC5803, IC5804, IC5805, IC5806, IC5807, IC5808, IC5809, IC5810, IC5811, IC5812, IC5813, IC5814, IC5896, IC5897, IC5898, IC5899, IC5900, IC5902, IC5903, IC5904, IC5905, IC5916, IC5918, IC5920, IC5921, IC5922, IC5923, IC5924, IC5925, IC5963, IC5964, IC5965, IC5966, IC5967, IC5968, IC6012, IC6013, IC6014, IC6015, IC6016, IC6017, IC6018, IC6019, IC6020, IC6021, IC6022, IC6023, IC6024, IC6025, IC6067, IC6068, IC6069, IC6070, IC6073, IC6074, IC6075, IC6116, IC6117, IC6120, IC6121, IC6122, IC6123, IC6124, IC6166, IC6167, IC6168, IC6169, IC6171, IC6172, IC6173, IC6174, IC6175, IC6226, IC6229, IC6230, IC6231, IC6232, IC6234, IC6235, IC6256, IC6257, IC6258, IC6259, IC6260, IC6265, IC6276, IC6278, IC6279, IC6280, IC6281, IC6282, IC6283, IC6297, IC6298, IC6299, IC6302, IC6303, IC6304, IC6305, IC6336, IC6337, IC6338, IC6339, IC6340, IC6341, IC6342, IC6343, IC6344, IC6345, IC6376, IC6377, IC6378, IC6379, IC6383, IC6384, IC6416, IC6417, IC6418, IC6421, IC6422, IC6460, IC6461, IC6462, IC6463, IC6465, IC6698, IC6703, IC6758, IC6776, IC6777, IC6779, IC6780, IC6781, IC6784, IC6785, IC6788, IC6789, IC6790, IC6791, IC6792, IC6793, IC6794, IC6795, IC6866, IC6867, IC6868, IC6869, IC6870, IC6871, IC6872, IC6873, IC6874, IC6875, IC6936, IC6937, IC6938, IC6939, IC6940, IC6941, IC6942, IC6943, IC6944, IC6945, IC6946, IC6949, IC6950, IC6951, IC6952, IC6954, IC6955, IC6986, IC6987, IC6988, IC7047, IC7048, IC7049, IC7050, IC7051, IC7052, IC7053, IC7054, IC7055, IC7156, IC7157, IC7158, IC7159, IC7160, IC7161, IC7163, IC7164, IC7226, IC7227, IC7232, IC7233, IC7234, IC7235, IC7266, IC7267, IC7268, IC7269, IC7270, IC7271, IC7272, IC7273, IC7274, IC7275, IC7356, IC7357, IC7358, IC7359, IC7360, IC7361, IC7362, IC7363, IC7364, IC7457, IC7458, IC7459, IC7460, IC7461, IC7462, IC7463, IC7464, IC7465, IC7523, IC7524, IC7525, IC7526, IC7528, IC7586, IC7587, IC7588, IC7589, IC7590, IC7620, IC7621, IC7622, IC7623, IC7624, IC7626, IC7627, IC7628, IC7710, IC7711, IC7738, IC7739, IC7792, IC7793, IC7821, IC7822, IC7823, IC7824, IC7826, IC7829, IC7830, IC7860, IC7863, IC7864, IC7865, IC7866, IC7867, IC7868, IC7869, IC7920, IC7939, IC7943, IC7944, IC7947, IC7953, IC7956, IC7958, IC7964, IC7965, IC8011, IC8012, IC8059, IC8060, IC8061, IC8063, IC8067, IC8068, IC8071, IC8073, IC8074, IC8075, IC8117, IC8118, IC8119, IC8122, IC8123, IC8124, IC8125, IC8145, IC8146, IC8159, IC8160, IC8161, IC8165, IC8201, IC8202, IC8203, IC8204, IC8205, IC8206, IC8217, IC8218, IC8219, IC8220, IC8221, IC8226, IC8252, IC8253, IC8254, IC8255, IC8256, IC8257, IC8258, IC8259, IC8260, IC8261, IC8262, IC8336, IC8340, IC8342, IC8344, IC8345, IC8395, IC8396, IC8397, IC8400, IC8403, IC8405, IC8421, IC8422, IC8423, IC8424, IC8439, IC8443, IC8444, IC8450, IC8457, IC8482, IC8486, IC8487, IC8499, IC8511, IC8512, IC8584, IC8586, IC8591, IC8592, IC8600, IC8610, IC8622, IC8625, IC8639, IC8643, IC8644, IC8645, IC8647, IC8648, IC8649, IC8661, IC8662, IC8663, IC8664, IC8690, IC8691, IC8693, IC8696, IC8723, IC8725, IC8726, IC8729, IC8737, IC8739, IC8931, IC8338, IC8339, IC8596, IC8608, IC8655, IC8665, IC8692, IC8761, IC8762, IC8813, IC9349, IC9372, IC7827, IC7828, IC8133, IC8134, IC9385, IC8404, IC8420, IC11746, IC12327, IC12344, IC13040, IC8425, IC8426, IC8427, IC8428, IC7861, IC7862, IC7954, IC7957, IC8120, IC8121, IC8222, IC8225, IC9027, IC9090, IC9091, IC8062, IC8066, IC5042, IC5129, IC5282, IC5580, IC5919, IC6118, IC6119, IC6261, IC6263, IC6459, IC7456, IC7529, IC7797, IC7941, IC7942, IC7955, IC8147, IC8442, IC8495, IC8513, IC8590, IC8753, IC8754, IC8755, IC8764, IC8765, IC9085, IC9230, IC9367, IC8875, IC9383, IC9796, IC9866, IC9974, IC10023, IC10024, IC9996, IC9998, IC11491, IC11451, IC11456, IC11497, IC11500, IC11741, IC11742, IC11745, IC11747, IC11748, IC11749; 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN; UDI-DI: 00813502011425; Serial Numbers: IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8609, IC8980, IC9177, IC9178, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970; 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK; UDI-DI: 00813502010978; Serial Numbers: IC8105, IC8106, IC8308, IC8315, IC8316, IC8335, IC8541, IC8542, IC8543, IC8895, IC9163, IC10013, IC10014, IC11023, IC11183, IC11442, IC12507, IC9133, IC9443, IC10012, IC10015, IC10039, IC10044, IC10319, IC10320, IC10640, IC10641, IC10645, IC10646, IC10648, IC10649, IC11019, IC11026, IC11027, IC11028, IC11048, IC11071, IC11086, IC11190, IC11201, IC11202, IC11441, IC11444, IC11445, IC11448, IC12503, IC12504, IC12579, IC12580, IC12581, IC12582, IC12719, IC12720, IC12721, IC12723, IC13159, IC13201, IC13204, IC13219, IC13220, IC13221, IC13278, IC13279, IC13280, IC8334, IC8767, IC8768, IC8774, IC9441, IC9445, IC9599, IC10040, IC10043, IC10808, IC11186, IC11211, IC11440, IC12505, IC12506, IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC8113, IC8114, IC8115, IC8116, IC8127, IC8129, IC8297, IC8331, IC8332, IC8333, IC8561, IC8563, IC8593, IC8594, IC9442, IC9444, IC9447, IC9448, IC9450, IC8295; 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US; UDI-DI: 00813502010985; Serial Numbers: IC11685, IC5970, IC5971, IC6956, IC6957, IC6958, IC6959, IC6960, IC6961, IC6962, IC6963, IC6964, IC6965, IC6966, IC6967, IC6968, IC6969, IC6970, IC6971, IC6972, IC6973, IC6974, IC6975, IC6996, IC6997, IC6998, IC6999, IC7000, IC7001, IC7002, IC7003, IC7004, IC7005, IC7006, IC7007, IC7009, IC7011, IC7012, IC7013, IC7014, IC7015, IC7016, IC7017, IC7018, IC7019, IC7020, IC7021, IC7022, IC7023, IC7024, IC7025, IC7036, IC7037, IC7038, IC7109, IC7110, IC7111, IC7112, IC7113, IC7114, IC7115, IC7116, IC7117, IC7118, IC7119, IC7120, IC7123, IC7125, IC7127, IC7128, IC7129, IC7130, IC7131, IC7132, IC7135, IC7136, IC7137, IC7138, IC7139, IC7150, IC7151, IC7152, IC7153, IC7154, IC7155, IC7166, IC7167, IC7168, IC7169, IC7170, IC7171, IC7172, IC7173, IC7174, IC7175, IC7176, IC7177, IC7178, IC7179, IC7192, IC7193, IC7194, IC7195, IC7196, IC7197, IC7198, IC7199, IC7200, IC7201, IC7202, IC7203, IC7204, IC7205, IC7206, IC7208, IC7209, IC7210, IC7211, IC7212, IC7213, IC7214, IC7215, IC7216, IC7217, IC7222, IC7223, IC7224, IC7225, IC7236, IC7237, IC7238, IC7239, IC7240, IC7241, IC7243, IC7244, IC7245, IC7246, IC7247, IC7249, IC7250, IC7251, IC7252, IC7253, IC7254, IC7255, IC7276, IC7277, IC7278, IC7279, IC7280, IC7281, IC7282, IC7283, IC7284, IC7285, IC7296, IC7297, IC7298, IC7299, IC7300, IC7301, IC7302, IC7303, IC7304, IC7305, IC7306, IC7307, IC7308, IC7313, IC7315, IC7316, IC7317, IC7318, IC7319, IC7320, IC7321, IC7322, IC7324, IC7325, IC7326, IC7327, IC7328, IC7329, IC7330, IC7331, IC7332, IC7333, IC7334, IC7335, IC7336, IC7337, IC7338, IC7344, IC7345, IC7346, IC7347, IC7348, IC7349, IC7350, IC7351, IC7352, IC7353, IC7354, IC7355, IC7366, IC7367, IC7368, IC7369, IC7370, IC7371, IC7372, IC7373, IC7374, IC7375, IC7396, IC7397, IC7398, IC7399, IC7400, IC7401, IC7402, IC7403, IC7404, IC7405, IC7466, IC7467, IC7468, IC7469, IC7470, IC7471, IC7472, IC7473, IC7474, IC7476, IC7477, IC7478, IC7479, IC7480, IC7481, IC7482, IC7483, IC7484, IC7485, IC7486, IC7487, IC7488, IC7489, IC7490, IC7491, IC7492, IC7493, IC7494, IC7495, IC7496, IC7497, IC7498, IC7499, IC7500, IC7501, IC7502, IC7503, IC7504, IC7505, IC7506, IC7507, IC7508, IC7509, IC7510, IC7511, IC7512, IC7513, IC7514, IC7515, IC7516, IC7517, IC7518, IC7534, IC7535, IC7536, IC7537, IC7538, IC7539, IC7540, IC7541, IC7542, IC7543, IC7544, IC7545, IC7547, IC7548, IC7549, IC7550, IC7551, IC7552, IC7553, IC7554, IC7555, IC7556, IC7557, IC7558, IC7559, IC7561, IC7564, IC7570, IC7573, IC7574, IC7599, IC7600, IC7601, IC7602, IC7603, IC7604, IC7605, IC7616, IC7617, IC7618, IC7619, IC7658, IC7659, IC7660, IC7661, IC7662, IC7663, IC7664, IC7665, IC7676, IC7677, IC7678, IC7679, IC7699, IC7700, IC7701, IC7702, IC7703, IC7704, IC7705, IC7706, IC7707, IC7712, IC7713, IC7714, IC7715, IC7726, IC7727, IC7728, IC7729, IC7730, IC7731, IC7732, IC7733, IC7734, IC7735, IC7736, IC7737, IC7742, IC7743, IC7744, IC7745, IC7756, IC7757, IC7758, IC7759, IC7760, IC7761, IC7771, IC7772, IC7773, IC7774, IC7775, IC7786, IC7787, IC7788, IC7789, IC7790, IC7791, IC7802, IC7803, IC7804, IC7805, IC7816, IC7817, IC7818, IC7819, IC7820, IC7877, IC7878, IC7879, IC7880, IC7882, IC7883, IC7884, IC7890, IC7893, IC7894, IC7906, IC7908, IC7974, IC8002, IC8003, IC8004, IC8006, IC8008, IC8026, IC8029, IC8034, IC8035, IC8037, IC8040, IC8041, IC10049, IC10066, IC10587, IC9228, IC9229, IC9610, IC9622, IC9773, IC9780, IC9781, IC9782, IC10102, IC10103, IC10318, IC10463, IC10589, IC10979, IC11299, IC12316, IC12758, IC12859, IC12900, IC13812, IC9989, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC11656, IC11670, IC11674, IC11677, IC12214, IC12279, IC12414, IC12415, IC12417, IC12418, IC12419, IC12820, IC12857, IC12858, IC12870, IC12885, IC12973, IC12974, IC13231, IC13263, IC13264, IC13265, IC13268, IC13270, IC13271, IC13681, IC13682, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC7010, IC12884, IC12953, IC13232, IC13698, IC12968, IC13212, IC13269, IC13862;
Distribution
Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;
Firm notified the public via
Letter
FDA event ID
99671
Recall initiated
August 12, 2026
FDA classified
September 16, 2026
FDA report date
September 23, 2026

More Abiomed recalls

Other medical device recalls from around the same time

Verify with the official sources:

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

Report a data error on this page