Recall Z-0724-2024— Maquet Cardiovascular, LLC
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-12-01. It names one FDA 510(k) clearance: K153194. Product: Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.. Reason: 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..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-01
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.