Drug recall
Impella RP Flex with SmartAssist. Product Code: 1000323.
FDA recall event 98276 · Class I · Abiomed, Inc.
Key facts
| Event ID | 98276 |
|---|---|
| Recall numbers | Z-1469-2026, Z-1470-2026, Z-1471-2026 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | Impella RP Flex with SmartAssist. Product Code: 1000323., Impella RP. Product Code: 0046-0011., Impella RP with SmartAssist. Product Code: 0046-0035. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| Initiation date | Jan 27, 2026 |
| Report date | Mar 11, 2026 |
| City | Danvers |
| State | MA |
| Country | United States |
| FEI number | 1220648 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: