Recall archive / FDA device enforcement
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in si... — FDA record Z-2468-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 225 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2468-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of Belgium, France, Germany, and United Kingdom.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 6, 2023
- Recall initiation date
- Jul 13, 2023
- Center classification date
- Aug 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.