Impella RP with SmartAssist. Product Code: 0046-0035.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | January 27, 2026 |
| Reported | March 11, 2026 |
| Recalling firm | Abiomed, Inc. |
| Country / region | United States MA |
Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Affected products
- Impella RP with SmartAssist. Product Code: 0046-0035.
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