FDA recall Z-0723-2024

Product

Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .

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.

Key facts

Status

Ongoing

Initiation date

2023-12-01

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2024