FDA recall notice
Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Pump…
FDA Recall Confirmed · Catheters · posted Aug 27, 2025
Key facts
| Notice | Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Pump Driver Circuit Assembly Issues |
|---|---|
| Device type | Catheters |
| Status | Recall Confirmed |
| Posted | Aug 27, 2025 |
| Notice on fda.gov | fda.gov |
At a glance
- Confirmed Recall confirmed
- Yes Currently listed by the FDA
- 1–9 Recall events referenced
- 1–9 UDI device identifiers named
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall notices and early alerts
The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts · Source date: