Device recall
Z-1282-2022: INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine…
FDA device recall · Class II · Maquet Cardiovascular, LLC
Key facts
| Recall number (Z-number) | Z-1282-2022 |
|---|---|
| Recall event | 90272 |
| Product | INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot… |
| Product code | DSY |
| Recalling firm | Maquet Cardiovascular, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2024 |
| 510(k) numbers | K984294 |
| FEI number | 2242352 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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