Recall Z-2468-2023 ยท MGZ Valvulotome
LeMaitre Vascular, Inc.
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic a
| Date | Aug 28, 2023 (initiated Jul 13, 2023) |
| Status | Open, Classified |
| Reason | Burrs (molding flash) on the cutter may tear the harvested vien |
| Root cause | Nonconforming Material/Component |
| Action | LeMaitre issued Field Safety Notice (FSN) Chevalier Valvulotome (FSCA Ref: CAPA 2023-022) on July 13, 2023 to OUS Customers. Letter states reason for recall, health risk and action to take: Please quarantine the affected devices. Then, return the faxback/reply form (at the end of this FSN) to LeMaitre Vascular as soon as possible. Then, LeMaitre will give you instructions on how to return the devices. |
| Quantity | 225 units |
| Distribution | International distribution to the countries of Belgium, France, Germany, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.