Early Alert: Heart Pump Controller Issue From Abiomed
Recall Summary Abiomed's Automated Impella Controller has a software error that may cause it to restart unexpectedly when used with left ventricular Impella heart pump devices. This is an early alert notification about the issue. The recall affects users of this heart pump controller system.
- Recalling firm
- Abiomed
- Product
- Heart Pump Controller
- Reason
- Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-09-23
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/0daa49c8-4b6f-48fe-bc8c-307e33afc2f9