Device recall
Z-1532-2021: Medtronic Abre Venous Self-expanding Sent System, Catalog number REF…
FDA device recall · Class II · Medtronic Inc.
Key facts
| Recall number (Z-number) | Z-1532-2021 |
|---|---|
| Recall event | 87638 |
| Product | Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. |
| Product code | QAN |
| Recalling firm | Medtronic Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2024 |
| PMA numbers | P200026 |
| FEI number | 2183870 |
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