Device recall
Z-1606-2010: EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight…
FDA device recall · Class II · Maquet Cardiovascular, LLC
Key facts
| Recall number (Z-number) | Z-1606-2010 |
|---|---|
| Recall event | 55317 |
| Product | EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair… |
| Product code | DSY |
| Recalling firm | Maquet Cardiovascular, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2012 |
| 510(k) numbers | K052964 |
| 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