Z-2468-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- July 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 225 units
Product Description
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)
Reason for Recall
Burrs (molding flash) on the cutter may tear the harvested vien
Distribution Pattern
International distribution to the countries of Belgium, France, Germany, and United Kingdom.
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