Device recall
Z-1063-06: 6F ZUMA EBU3.5 W/110CM LENGTH CATHETER ZM6EBU35A ZM 6F 110CM EB35 Coronary…
FDA device recall · Class II · Medtronic, Inc.
Key facts
| Recall number (Z-number) | Z-1063-06 |
|---|---|
| Recall event | 35236 |
| Product | 6F ZUMA EBU3.5 W/110CM LENGTH CATHETER ZM6EBU35A ZM 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU35A |
| Product code | DQY |
| Recalling firm | Medtronic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 20, 2007 |
| 510(k) numbers | K981198 |
| FEI number | 1220452 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 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