Official recall notice
FDA DeviceClass INotable
FDA Recall: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll
- Recall date
- 2026-06-24
- Brand
- Abiomed, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Recommended action
What to do
10,297 units
Product description
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.