Recall Z-0228-2023 ยท DXE Catheter, Embolectomy
LeMaitre Vascular, Inc.
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..
| Date | Nov 11, 2022 (initiated Sep 30, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| Action | On September 30, 2022, the recalling firm notified affected customers via Urgent Field Safety Notice letters. Users were instructed to immediately identify, quarantine, and return the affected devices. |
| Quantity | 72 (OUS only) |
| Distribution | No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992368 | LEMAITRE EMBOLECTOMY CATHETER Vascutech, Inc., Dec 9, 1999 |