FDAClass I · Medical device · Recall Z-2211-2026 · Recalled June 3, 2026
Automated Impella Controller (AIC) recall — Abiomed, Inc.
Agency report date: June 3, 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
Automated Impella Controller (AIC); Product Code: 0042-0000-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: A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
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: Automated Impella Controller (AIC) 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
- Atlan A350XL recall — Draeger, Inc.FDA · June 10, 2026
- Atlan A350 recall — Draeger, Inc.FDA · June 10, 2026
- Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.FDA · June 3, 2026
- Medline kits containing Huons Co recall — Medline Industries, LPFDA · June 3, 2026
- Medline kits containing Huons Co recall — Medline Industries, LPFDA · June 3, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
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 September 1, 2026 at 6:00 PM UTC.