Drug recall
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During…
FDA recall event 84025 · Class II · Abiomed, Inc.
Key facts
| Event ID | 84025 |
|---|---|
| Recall numbers | Z-0345-2020 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10… |
| Initiation date | Sep 4, 2019 |
| Report date | Nov 13, 2019 |
| Termination date | Jan 21, 2020 |
| 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: