Maquet Cardiovascular, LLC is recalling approximately 3,063 units of the Vasoview Hemopro and Hemopro 2 Endoscopic Vessel Harvesting Systems after 27 complaints regarding a straightened C-Ring wire and incorrect spacing between the ring and the harvesting tool. These systems are used by surgical teams to harvest blood vessels for bypass procedures. The defect could lead to technical difficulties or unintended tissue contact during surgery, although no adverse events or injuries have been reported to date. Affected models include VH-3500, VH-4000, and VH-4001 distributed throughout the United States and several international locations.
The C-Ring wire can straighten due to an insufficient bend radius, causing the harvesting tool and C-Ring to be closer than intended. This mechanical failure can compromise the surgical procedure's precision and potentially lead to vessel damage or increased surgical time.
Manufacturer notification and contact
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.
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Sources: FDA iRES ยท Raw API Response
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