Device recall
Z-0507-2020: The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two…
FDA device recall · Class II · Nucryo Vascular Inc.
Key facts
| Recall number (Z-number) | Z-0507-2020 |
|---|---|
| Recall event | 84134 |
| Product | The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths. The balloon has… |
| Product code | LIT |
| Recalling firm | Nucryo Vascular Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2021 |
| 510(k) numbers | K152665 |
| FEI number | 3011393614 |
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