Heart Pump Controller Correction: Abiomed Updates Use Instructions For Automated Impella Controllers
Recall Summary Abiomed is correcting the instructions for Automated Impella Controllers due to a software error that may cause the device to unexpectedly restart when used with certain heart pump devices. The restart could interrupt the operation of the heart pump system. This affects patients using Automated Impella Controllers with left ventricular Impella devices.
- Product
- Automated Impella Controllers
- Reason
- A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-06-22
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/32c86974-be5d-4da7-b0dc-4e75f2b97625