Recall Z-2468-2023— LeMaitre Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2023-07-13. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: Burrs (molding flash) on the cutter may tear the harvested vien.
- Recalling firm
- LeMaitre Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-13
- Firm location
- Burlington, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.