Device recall
Z-0257-2025: Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-0257-2025 |
|---|---|
| Recall event | 95447 |
| Product | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm… |
| Product code | LIT |
| Recalling firm | Covidien LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K163231 |
| FEI number | 1282497 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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