Drug recall
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella…
FDA recall event 93876 · Class II · Abiomed, Inc.
Key facts
| Event ID | 93876 |
|---|---|
| Recall numbers | Z-1175-2024 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the… |
| Initiation date | Mar 1, 2021 |
| Report date | Feb 28, 2024 |
| Termination date | Mar 6, 2025 |
| 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: