Device recall
Z-2945-2024: Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following…
FDA device recall · Class II · W L Gore & Associates, Inc.
Key facts
| Recall number (Z-number) | Z-2945-2024 |
|---|---|
| Recall event | 94971 |
| Product | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A… |
| Product code | PRL |
| Recalling firm | W L Gore & Associates, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2017233 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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