Class II

Medical Device Recall: Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.

Maquet Cardiovascular, LLC · December 1, 2023

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 Affected

38,094 units (US)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0724-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Maquet Cardiovascular, LLC Medical Device Recall: Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. | SafeCheck