FDA-Device2024-01-24Class II
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Maquet Cardiovascular, LLC
Hazard
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.
Sold states
US: OUS: China, Brazil, Hong Kong.
Affected count
554 units (OUS)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2024Don't want to check this manually?
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