Heart Pump Correction: Abiomed Issues Correction For Automated Impella Controllers
Abiomed is correcting certain Automated Impella Controllers (heart pump devices) that may need hardware updates to fix potential safety issues. These issues could cause delays or loss of the hemodynamic support the device provides to the heart. The correction affects users of specific AIC units.
- Product
- Automated Impella Controllers
- Reason
- Certain AIC units require hardware updates to address potential safety concerns that could lead to a delay or loss of hemodynamic support.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-06-11
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/7fe7c241-f758-4898-bea6-4fe177306c26