Reported Jan 24, 2024 · Ongoing
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
- Lot codes and dates
- UDI-DI00607567701250
- Lots
101 of 101 codes
300027926630002801893000281082300028108330002813813000282927300028315630002817413000286706300028725430002883633000288576300028902030002895483000289927300029048230002914293000291157300029164530002920983000293522300029378830002938233000295050300029436530002953463000296172300029602130002964983000297028300030001630002998543000300155300030026030003010423000301666300030276030003032823000303854300030491230003046453000306277300030643730003070903000307871300030872530003106913000311127300031152530003118923000312494300031272230003143733000314821300031602330003160273000316024300031757630003175013000317575
- Amount recalled
- 38,094 units (US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
This product could cause temporary or reversible health problems — stop using it.
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