FDA recall notice
Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist…
FDA Recall Confirmed · Heart Pump · posted Feb 14, 2025
Key facts
| Notice | Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal |
|---|---|
| Device type | Heart Pump |
| Status | Recall Confirmed |
| Posted | Feb 14, 2025 |
| Notice on fda.gov | fda.gov |
At a glance
- Confirmed Recall confirmed
- Yes Currently listed by the FDA
- None 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: