Device recall
Z-1276-2015: Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select…
FDA device recall · Class I · Medtronic Inc. Cardiac Rhythm Disease Management
Key facts
| Recall number (Z-number) | Z-1276-2015 |
|---|---|
| Recall event | 70644 |
| Product | Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable. |
| Product code | DYB |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 7, 2015 |
| 510(k) numbers | K142684 |
| FEI number | 2182208 |
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