Device recall
Z-0346-2025: Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part…
FDA device recall · Class II · Cook Incorporated
Key facts
| Recall number (Z-number) | Z-0346-2025 |
|---|---|
| Recall event | 95528 |
| Product | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G |
| Product code | DQX |
| Recalling firm | Cook Incorporated |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171897 |
| FEI number | 1820334 |
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