Device recall
Z-1940-2020: Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1940-2020 |
|---|---|
| Recall event | 85456 |
| Product | Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned… |
| Product code | NIN |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2024 |
| PMA numbers | P100028 |
| FEI number | 1820334 |
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