Device recall
Z-1055-06: ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding…
FDA device recall · Class II · Medtronic, Inc.
Key facts
| Recall number (Z-number) | Z-1055-06 |
|---|---|
| Recall event | 35236 |
| Product | ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 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: ZM5SR35 |
| Product code | DQY |
| Recalling firm | Medtronic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 20, 2007 |
| 510(k) numbers | K990707 |
| 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