FDA DevicesClass I
Impella RP. Product Code: 0046-0011.
Published: March 11, 2026Recall ID: Z-1471-2026Category: devicesCountry: US
Reason for Recall / Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Product Description & Identification
Impella RP. Product Code: 0046-0011.
Additional Source Details
| Field | Value |
|---|---|
| City | Danvers |
| State | MA |
| Event id | 98276 |
| Address 1 | 22 Cherry Hill Dr |
| Address 2 | N/A |
| Code info | Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US. |
| Postal code | 01923-2575 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 179 units |
| Reason for recall | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260127 |
| Initial firm notification | Letter |
| Center classification date | 20260227 |
Overview
- Recalling FirmAbiomed, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.