Recall Z-1750-2025 ยท DXE Catheter, Embolectomy
LeMaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
| Date | May 12, 2025 (initiated Apr 11, 2025) |
| Status | Open, Classified |
| Reason | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| Root cause | Packaging process control |
| Action | LeMaitre notified OUS consignees beginning on 04/11/2025, and US consignees on 04/23/2025 via email and letter. Consignees were instructed to not use the devices, immediately quarantine any on hand, and complete and return the response form. Once received a LeMaitre Vascular representative will contact customers to provide return instructions. If the products were transferred or further distributed, customers were instructed to notify those customers and provide a copy of the recall letter. |
| Quantity | 237,611 units |
| Distribution | Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HON |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LeMaitre Vascular, Inc., Jan 14, 2003 |