Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect
LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall involving a surgical instrument with a manufacturing defect (burrs) that could cause tissue damage to harvested veins. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High rating.
Plain-English summary
LeMaitre Vascular, Inc. is recalling specific lots of the Chevalier Valvulotome, a surgical instrument used to disrupt valve tissue in veins that will be used as grafts in bypass procedures. The recalled device consists of a 70 cm stainless steel shaft with two tips: a cutting tip shaped like an inverted tulip and an atraumatic tip for testing vein patency.
The recall has been initiated because burrs (molding flash) may be present on the cutting tip of affected units. These burrs could tear the harvested vein during the surgical procedure.
The recall applies to 225 units distributed to Belgium, France, Germany, and the United Kingdom. Affected units have lot numbers beginning with CHV: CHV1001, CHV1002, CHV1003, CHV1004, CHV1005, CHV1006, and CHV1022. Older lot numbers beginning with CL are not affected. The three catalog numbers involved are 40025 (2.5 mm tip), 40030 (3.0 mm tip), and 40035 (3.5 mm tip).
The recalled product
- 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 invert
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- molding-defect
- tissue-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- (1)Catalog # 40025 UDI-DI: 00840663110469
- (2)Catalog # 40030 UDI-DI: 00840663110476
- CHV1006
- CHV1022 (2) 40030 Lot Number: CHV1002
- CHV1004
- (3) 40035 Lot Number: CHV1001
- CHV1005
Distribution
Distribution scope not specified by the agency.
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