Device recall
Z-1077-2022: iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403…
FDA device recall · Class I · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-1077-2022 |
|---|---|
| Recall event | 89852 |
| Product | iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453 85454 85455 Product Code/UDI /Description: 85400… |
| Product code | JCT |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K050814 |
| FEI number | 3011175548 |
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