Drug recall
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
FDA recall event 92411 · Class I · Abiomed, Inc.
Key facts
| Event ID | 92411 |
|---|---|
| Recall numbers | Z-2281-2023 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and… |
| Initiation date | Jun 29, 2023 |
| Report date | Aug 9, 2023 |
| 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: