Drug recall
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS)…
FDA recall event 94973 · Class II · Thoratec LLC
Key facts
| Event ID | 94973 |
|---|---|
| Recall numbers | Z-2583-2024 |
| Recalling firm | Thoratec LLC |
| Product type | Devices |
| Products | HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed… |
| Initiation date | Jun 25, 2024 |
| Report date | Aug 21, 2024 |
| City | Pleasanton |
| State | CA |
| Country | United States |
| FEI number | 2916596 |
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: