Recall Z-0117-2027 ยท DXE Catheter, Embolectomy
LeMaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
| Date | Oct 7, 2026 (initiated Aug 28, 2026) |
| Status | Open, Classified |
| Reason | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. |
| Root cause | Under Investigation by firm |
| Action | On August 28, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. 2. Complete the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory. 3. LeMaitre customer service will provide an RMA number to coordinate the product return. 4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. 5. If you have transferred devices to another facility, pleas |
| Quantity | 54 |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC. |
| 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 |