Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Reported: January 24, 2024 Initiated: December 1, 2023 #Z-0723-2024
Product Description
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.
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- 554 units (OUS)
- Distribution
- US: OUS: China, Brazil, Hong Kong.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .. Recalled by Maquet Cardiovascular, LLC. Units affected: 554 units (OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0723-2024.
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