BEUDAMED
    FDA Enforcement Class I Ongoing

    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.

    Recall: Z-0712-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0712-2025
    Event ID
    95908
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 15, 2025
    Initiation Date
    December 9, 2024
    Classification Date
    January 3, 2025
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States

    Description

    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.

    Reason

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

    Code Info

    Model Number: VH-4001. UDI-DI: 00607567700451. All unexpired Lots.

    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, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.

    Quantity

    11,101 units US