Device recall
Z-1567-2020: LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84…
FDA device recall · Class I · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-1567-2020 |
|---|---|
| Recall event | 85193 |
| Product | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a… |
| Product code | DXE |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K022145 |
| 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