Impella RP Flex with SmartAssist. Product Code: 1000323.
USImpella RP Flex with SmartAssist. Product Code: 1000323.
Recalling Firm: Abiomed, Inc.
Reason for Recall / Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Product Description & Identification
Impella RP Flex with SmartAssist. Product Code: 1000323.
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: 1000323. UDI-DI: 00813502012811. |
| Postal code | 01923-2575 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 4,496 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 |
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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.
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🚨 SAFETY ALERT: Abiomed, Inc. - Impella RP Flex with SmartAssist. Product Code: 1000323. Check if your household is affected: https://therecallfile.com/recalls/impella-rp-flex-with-smartassist-product-code-1000323/FDA-Z-1470-2026
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