Device recall
Z-0154-2014: Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent…
FDA device recall · Class II · Medtronic Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-0154-2014 |
|---|---|
| Recall event | 66532 |
| Product | Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients. |
| Product code | NIQ |
| Recalling firm | Medtronic Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2014 |
| PMA numbers | P110013, P110013S005 |
| FEI number | 3001452571 |
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