Drug recall
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1)…
FDA recall event 93746 · Class II · Abiomed, Inc.
Key facts
| Event ID | 93746 |
|---|---|
| Recall numbers | Z-1074-2024 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device. |
| Initiation date | Dec 27, 2023 |
| Report date | Feb 21, 2024 |
| 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: