Device product
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 and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)
Z-2468-2023
Product summary
- Event
- Event 92825
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 225 units
- Official record key
device-enforcement:Z-2468-2023
Official wording
Reason: Burrs (molding flash) on the cutter may tear the harvested vien
Code information: (1)Catalog # 40025 UDI-DI: 00840663110469; (2)Catalog # 40030 UDI-DI: 00840663110476; (3) Catalog # 40035 UDI-DI: 00840663110483 Lot Numbers: All lots starting with CHV. Only lots beginning with CHV are being recalled. Older lots (with CL lot prefixes) are not being recalled. REF (Catalog #) LOT Catalog Number: (1)40025 Lot Number: CHV1003, CHV1006, CHV1022 (2) 40030 Lot Number: CHV1002, CHV1004, (3) 40035 Lot Number: CHV1001, CHV1005
Distribution pattern: International distribution to the countries of Belgium, France, Germany, and United Kingdom.
Derived failure modes
-
Unknown
Burrs (molding flash) on the cutter may tear the harvested vien