The Chevalier Valvulotome is a device used to disrupt the valves of… — Class II medical device recall Z-2468-2023
Ongoing recall by LeMaitre Vascular, Inc., reported 2023-09-06. Burrs (molding flash) on the cutter may tear the harvested vien
| Recall number | Z-2468-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2023-07-13 |
| Classified | 2023-08-28 |
| Reported by FDA | 2023-09-06 |
| Countries outside the US | BE, DE, FR, GB |
| Quantity | 225 units |
| UPC / GTIN / UDI-DI | 00840663110469, 00840663110476, 00840663110483 |
| Lot numbers | CHV1001, CHV1002, CHV1003, CHV1004, CHV1005, CHV1006, CHV1022 |
| Model numbers | 40025, 40030, 40035, CHV1001, CHV1002, CHV1003, CHV1004, CHV1005, CHV1006, CHV1022 |
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 for recall
Burrs (molding flash) on the cutter may tear the harvested vien
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2468-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.