Device recall
Z-0597-2007: ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number…
FDA device recall · Class II · Kensey Nash Corp
Key facts
| Recall number (Z-number) | Z-0597-2007 |
|---|---|
| Recall event | 37393 |
| Product | ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow. |
| Product code | MCW |
| Recalling firm | Kensey Nash Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 12, 2007 |
| 510(k) numbers | K060016 |
| FEI number | 1000307073 |
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