Device recall
Z-1135-2013: Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-1135-2013 |
|---|---|
| Recall event | 64747 |
| Product | Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. |
| Product code | NPT |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2013 |
| PMA numbers | P100041, P110021 |
| FEI number | 1713910 |
At a glance
- None 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