Drug recall
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA recall event 92321 · Class I · Abiomed, Inc.
Key facts
| Event ID | 92321 |
|---|---|
| Recall numbers | Z-2111-2023, Z-2112-2023, Z-2113-2023, Z-2114-2023, Z-2115-2023, Z-2116-2023 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | Impella 2.5 intravascular micro axial blood pump, Product Number 005042, Impella 5.0 intravascular micro axial blood pump, Product Number 005062, Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100, Impella CP intravascular micro axial blood pump, Product Number 0048-0032, Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080 and 1 more |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller… |
| Initiation date | Jun 14, 2023 |
| Report date | Jul 26, 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: