Drug recall
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA recall event 94232 · Class I · Thoratec Corp.
Key facts
| Event ID | 94232 |
|---|---|
| Recall numbers | Z-1692-2024, Z-1693-2024 |
| Recalling firm | Thoratec Corp. |
| Product type | Devices |
| Products | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly, Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. |
| Initiation date | Mar 1, 2024 |
| Report date | May 8, 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: