Device recall
Z-0228-2023: TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a…
FDA device recall · Class II · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-0228-2023 |
|---|---|
| Recall event | 91006 |
| Product | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F.. |
| Product code | DXE |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K992368 |
| FEI number | 1220948 |
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