Recall Z-1824-2024 ยท DXE Catheter, Embolectomy
LeMaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
| Date | May 15, 2024 (initiated Apr 17, 2024) |
| Status | Open, Classified |
| Reason | The guide tip can become damaged and result in the tip detaching. |
| Root cause | Under Investigation by firm |
| Action | Consignees were mailed an URGENT MEDICAL DEVICE RECALL Notification, dated 4/10/2024. The notification instructs consignees to inspect their inventory for and quarantine affected devices, complete and return the provided Response Form to recalls@lamaitre.com, and return affected devices for credit. If product was further distributed, the recall notification is to be forwarded for customer awareness. Consignees with any questions are to contact Rose Lerer at rlerer@lemaitre.com from Monday through Friday, 8:00 AM to 4:30 PM EST. |
| Quantity | 5,604 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910372 | INTIMAX THROMBECTOMY CATHETER Applied Vascular Devices, Inc., Apr 26, 1991 |