FDA recall notice
Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella…
FDA Recall Confirmed · Blood Pump Controller · posted Dec 22, 2025
Key facts
| Notice | Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers |
|---|---|
| Device type | Blood Pump Controller |
| Status | Recall Confirmed |
| Posted | Dec 22, 2025 |
| Notice on fda.gov | fda.gov |
At a glance
- Confirmed Recall confirmed
- Yes Currently listed by the FDA
- 1–9 Recall events referenced
- None 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: