Device recall
Z-2349-2019: Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF…
FDA device recall · Class II · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-2349-2019 |
|---|---|
| Recall event | 83357 |
| Product | Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266 |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2020 |
| PMA numbers | 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