FDA-Device2025-01-15Class I
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Maquet Cardiovascular, LLC
Hazard
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Sold states
Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.
Affected count
11,101 units US
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0712-2025Don't want to check this manually?
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