The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ
FDA device recall Z-2468-2023 · posted 2023-08-28 · Open, Classified
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- Burrs (molding flash) on the cutter may tear the harvested vien
- Action taken
- LeMaitre issued Field Safety Notice (FSN) Chevalier Valvulotome (FSCA Ref: CAPA 2023-022) on July 13, 2023 to OUS Customers. Letter states reason for recall, health risk and action to take: Please quarantine the affected devices. Then, return the faxback/reply form (at the end of this FSN) to LeMaitre Vascular as soon as possible. Then, LeMaitre will give you instructions on how to return the devices.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MGZ
- Quantity affected
- 225 units
- Distribution
- International distribution to the countries of Belgium, France, Germany, and United Kingdom.
- Date initiated
- 2023-07-13
- Date posted
- 2023-08-28
- Location
- Burlington, MA
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