Drug recall
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
FDA recall event 98770 · Class I · Abiomed, Inc.
Key facts
| Event ID | 98770 |
|---|---|
| Recall numbers | Z-2211-2026 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | Automated Impella Controller (AIC); Product Code: 0042-0000-US; |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s… |
| Initiation date | Apr 20, 2026 |
| Report date | Jun 3, 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: