FDAClass I · Medical device · Recall Z-2602-2026 · Recalled July 1, 2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.
Agency report date: July 1, 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.
Agency product description and boundaries
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
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: Potential for thrombus formation during prolonged use of the introducer.
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: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
More Abiomed recalls
- Impella Optical Controller recall — Abiomed, Inc.FDA · September 23, 2026
- Impella Optical Controller with the below product descriptions and corresponding Product C recall — Abiomed, Inc.FDA · September 23, 2026
- Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.FDA · September 23, 2026
- ABIOMED Intro Kit recall — Abiomed, Inc.FDA · July 22, 2026
- ABIOMED Insertion Kit recall — Abiomed, Inc.FDA · July 22, 2026
Other medical device recalls from around the same time
- Hillrom VOLARA System P recall — Baxter Healthcare CorporationFDA · July 8, 2026
- Breathing circuit set recall — Hamilton Medical AGFDA · July 8, 2026
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.FDA · July 1, 2026
- Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.FDA · July 1, 2026
- Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.FDA · July 1, 2026
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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 September 29, 2026 at 6:00 PM UTC.