Device recall
Z-0642-2009: Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L…
FDA device recall · Class III · Medtronic Cardiovascular
Key facts
| Recall number (Z-number) | Z-0642-2009 |
|---|---|
| Recall event | 50476 |
| Product | Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system. |
| Product code | FGE |
| Recalling firm | Medtronic Cardiovascular |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 27, 2009 |
| 510(k) numbers | K062264 |
| FEI number | 3003311129 |
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