Device recall
Z-1921-2024: Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US…
FDA device recall · Class I · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-1921-2024 |
|---|---|
| Recall event | 94478 |
| Product | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P060040, P160054 |
| 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