The FDA announced on July 13, 2023, that LeMaitre Vascular, Inc. is recalling The Chevalier Valvulotome devices due to burrs on the cutter that may tear harvested veins. This voluntary Class II recall affects 225 units distributed internationally.
How to tell if you have it
- Brand: LeMaitre Vascular
- Product: The Chevalier Valvulotome
- Catalog # 40025, Lot Numbers CHV1003, CHV1006, CHV1022
- Catalog # 40030, Lot Numbers CHV1002, CHV1004
- Catalog # 40035, Lot Numbers CHV1001, CHV1005
The hazard
The device features a cutter with burrs (molding flash) that may tear the harvested vein during use. The recall involves lots starting with CHV; older lots with CL prefixes are not affected.
Context
GovInfoNow's records show LeMaitre Vascular, Inc. has had 12 other recalls since June 19, 2018. Recent similar recalls include the Artegraft Vascular Graft Recall due to labeling mix-up on Feb. 10, 2026, and the Artegraft Collagen Vascular Graft Recall for wrong size packaging on Sept. 25, 2025. Other recent recalls of similar products include the Clariance Elegance Cervical Plates Recall due to burr quality issues on Feb. 20, 2026, and the Merit Medical BioFlo DuraMax Catheter Recall for a design defect that may cause bleeding on Feb. 13, 2026.