Device recall
Z-0293-2018: Certitude Delivery System and any associated Multipacks Models - 9600CT20A…
FDA device recall · Class I · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-0293-2018 |
|---|---|
| Recall event | 78738 |
| Product | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo)… |
| Product code | NPT |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 13, 2019 |
| PMA numbers | P140031 |
| 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