BEUDAMED
    FDA Recall Open, Classified

    VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

    Recall: Z-0092-2025 · Initiated September 20, 2024

    Recall

    Recall Number
    Z-0092-2025
    Event Number
    95434
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 20, 2024
    Posted
    October 25, 2024
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

    Reason

    There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

    Action

    An URGENT MEDICAL DEVICE- REMOVAL notification letter dated 9/20/24 was sent to customers. Actions to be taken by the customer: 1. Forward this information to all current and potential VasoView HemoPro Endoscopic Vessel Harvesting System users within your hospital/facility. 2. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. 3. Examine your inventory immediately to find and remove from use any of the VasoView HemoPro EVH Systems with the product codes and lot numbers listed in this notice. 4. Return any unused/unexpired affected product to MCV /Getinge. Contact MCV/Getinge Customer Service at 1-888-880-2874 between 6 am and 5 pm PST (Pacific Standard Time) to request a return authorization number (RMA) and shipping instructions. If you have an affected product, you are entitled to a credit. 5. Whether or not you have affected the product, please complete and sign the MEDICAL DEVICE REMOVAL - RESPONSE FORM (page 5) to acknowledge receipt of this notification. Return the completed form to MCV/Getinge by emailing a scanned copy to [email protected] or by faxing the form to + 1 (866) 594 8101. Actions to be taken by Getinge: MCV/Getinge is continuing to investigate this issue to determine and implement appropriate actions to prevent the recurrence of this failure. MCV /Getinge will notify customers if additional action is needed to address this issue. Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products. This removal only affects the products listed on page 1; no other products are affected by this medical device removal. If you have any questions, contact your MCV /Getinge representative or call the MCV/Getinge Customer Support at 1-888-880-2874, Monday through Friday, between 6 am and 5 pm PST.

    Distribution

    Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.

    Quantity

    28,809 units