Device recall
Z-2448-2019: The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex…
FDA device recall · Class II · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-2448-2019 |
|---|---|
| Recall event | 83535 |
| Product | The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to… |
| Product code | MJN |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2020 |
| 510(k) numbers | K132022 |
| 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