Maquet Cardiovascular, LLC: Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .

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.

Details from the source

Reason for recall: 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. Distribution: US: OUS: China, Brazil, Hong Kong. Quantity: 554 units (OUS) Lot/code info: UDI-DI: 00607567700413, Lots: 3000283735, 3000293031, 3000310304, 3000333956.

UPC codes

00607567700413

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.