Device recall
Z-1203-2019: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional…
FDA device recall · Class II · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-1203-2019 |
|---|---|
| Recall event | 82458 |
| Product | 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 intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2022 |
| PMA numbers | P160054, P160054S005 |
| FEI number | 2916596 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database