Device recall
Z-0557-2022: Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon…
FDA device recall · Class II · Covidien Llc
Key facts
| Recall number (Z-number) | Z-0557-2022 |
|---|---|
| Recall event | 89418 |
| Product | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US |
| Product code | LIT |
| Recalling firm | Covidien Llc |
| 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