LeMaitre Vascular, Inc. Recall 91006
Description: 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..
LeMaitre Vascular, Inc. Recall 91006 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0228-2023 |
| Event ID | 91006 |
| Event Description | 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 Type | Devices |
| Distribution | No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy. |
| Quantity | 72 (OUS only) |
| Recall Reason | Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel. |
| Device Classification | 20221123 |
| Device Code Info | Lots XSL0097, XSL0098, and XSL0099 |
| Center Classification Date | 20221111 |
| Recall Initiation Date | 20220930 |
| Recalling Firm | LeMaitre Vascular, Inc. |
| Initial Notification | Letter |
| Similar To |