Device recall
Z-1367-2011: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange…
FDA device recall · Class II · Medtronic Vascular Galway Limited
Key facts
| Recall number (Z-number) | Z-1367-2011 |
|---|---|
| Recall event | 53012 |
| Product | Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in… |
| Product code | NIQ |
| Recalling firm | Medtronic Vascular Galway Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2011 |
| FEI number | 3002806434 |
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