FDA Device recall Z-2468-2023
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 byp…
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of 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 byp… by Lemaitre Vascular, citing burrs (molding flash) on the cutter may tear the harvested vien.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2468-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-13 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Lemaitre Vascular |
| Distribution | n/a |
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
Identifiers
| code_info | (1)Catalog # 40025 UDI-DI: 00840663110469; (2)Catalog # 40030 UDI-DI: 00840663110476; (3) Catalog # 40035 UDI-DI: 00840…(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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2468-2023%22
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