Device recall
Z-3186-2011: Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Management
Key facts
| Recall number (Z-number) | Z-3186-2011 |
|---|---|
| Recall event | 59477 |
| Product | Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is… |
| Product code | DRA |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2012 |
| 510(k) numbers | K102176 |
| FEI number | 2182208 |
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