FDA Class I recall: alarm and electrical faults in the controller (AIC) for the Impella heart pump — distributed worldwide (Abiomed)
Abiomed recalled the Automated Impella Controller (AIC), the console for its Impella circulatory-support pump, after identifying alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing. The FDA classified it Class I, the most serious. Distributed across the U.S. and Europe.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmAbiomed, Inc.
- ReasonRetrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom...
- Recall initiated2011-01-17
Key points
- Impella circulatory-support pump controller (AIC): alarm, power, short-circuit, and motor-sensing faults
- Purge-cassette misalignment can cause a piston block, requiring a switch to a backup console
- FDA classified it Class I (Z-2238-2026, reported June 3, 2026, ongoing)
- 625 units; distributed across the U.S. plus Canada, several European countries, and Kuwait
- Impella is tied to life support — controller faults seriously affect patient safety
1A Class I device recall
The U.S. FDA classified Abiomed's device recall as Class I — its most serious class (use may cause serious adverse health consequences or death) — recall number Z-2238-2026, reported June 3, 2026, status ongoing.
2Impella and its controller (AIC)
The affected product is the Automated Impella Controller (AIC). Impella is a small circulatory-support pump (a catheter-based heart pump placed within the heart) that temporarily supports blood circulation in patients whose heart pumping function is reduced; the AIC is the console that drives and monitors that pump.
3Alarm failures and power-path faults
The reasons (a retrospective submission) include: (1) alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing identified in certain AIC consoles; and (2) improper alignment between the purge cassette and the motor drive, which can cause a piston-block event so that purge-system priming cannot be completed, requiring the user to switch to a backup AIC console.
The quantity is 625 units; distribution spans the U.S. nationwide plus Canada, Denmark, France, Germany, Italy, Kuwait, the Netherlands, and others.
Why it matters
A Class I recall of the controller for a life-supporting circulatory device, distributed across several markets in the Americas and Europe. A useful pointer for hospital clinical-engineering and patient-safety teams to check affected models and actions.
FAQ
What is Impella?
Why is it Class I (most serious)?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2238-2026