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FDA (Device enforcement)Recalled 2024-12-09class i

Maquet Cardiovascular, LLC: Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel ha

Hazard

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

Details from the source

Reason for recall: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool Distribution: 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, So Quantity: 11,101 units US Lot/code info: Model Number: VH-4001. UDI-DI: 00607567700451. All unexpired Lots.

UPC codes

00607567700451

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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