Drug recall
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec…
FDA recall event 82458 · Class II · Thoratec Corp.
Key facts
| Event ID | 82458 |
|---|---|
| Recall numbers | Z-1203-2019 |
| Recalling firm | Thoratec Corp. |
| Product type | Devices |
| Products | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Small black plastic particle was observed in the left ventricle during implant procedure. |
| Initiation date | Mar 1, 2019 |
| Report date | May 1, 2019 |
| Termination date | Aug 10, 2022 |
| 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: