Device recall
Z-2039-2020: Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for…
FDA device recall · Class I · Medtronic Vascular Galway DBA Medtronic Ireland
Key facts
| Recall number (Z-number) | Z-2039-2020 |
|---|---|
| Recall event | 85649 |
| Product | Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. |
| Product code | DYB |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 10, 2022 |
| 510(k) numbers | K181817 |
| FEI number | 3002806434 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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