Official recall notice
FDA DeviceClass INotable
FDA Recall: Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1
- Recall date
- 2026-04-08
- Brand
- Abiomed, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
Recommended action
What to do
62 units
Product description
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.