Device recall
Z-0048-2018: GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic…
FDA device recall · Class II · W L Gore & Associates, Inc.
Key facts
| Recall number (Z-number) | Z-0048-2018 |
|---|---|
| Recall event | 78132 |
| Product | GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta. |
| Product code | MIH |
| Recalling firm | W L Gore & Associates, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2019 |
| PMA numbers | P040043 |
| FEI number | 2017233 |
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