LeMaitre Vascular is recalling 225 units of the Chevalier Valvulotome, a surgical device used to prepare veins for bypass procedures. The recall was initiated because molding flash (excess material or burrs) may be present on the device's cutter, which can lead to tearing of the harvested vein during surgery. Affected models include Catalog numbers 40025, 40030, and 40035, specifically those with lot numbers starting with 'CHV'. Consumers and healthcare providers should contact the manufacturer immediately to return any affected inventory.
The presence of sharp burrs or molding flash on the cutting tip can cause unintended mechanical damage or tearing of the vein wall while the surgeon is attempting to disrupt vein valves. This defect could compromise the integrity of the vein intended for use as a bypass graft, potentially leading to surgical complications or the need for a different graft source.
Manufacturer notification and product return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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