BEUDAMED
    FDA Recall Open, Classified

    VenaSeal Closure System

    Recall: Z-1564-2021 · Initiated March 23, 2021

    Recall

    Recall Number
    Z-1564-2021
    Event Number
    87619
    Firm
    Medtronic Inc.
    FEI Number
    2183870
    Product Code
    PJQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 23, 2021
    Address
    4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    VenaSeal Closure System

    Reason

    Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

    Action

    A Recall notification letter titled, "URGENT: MEDICAL DEVICE CORRECTION" was sent to consignees on 03/23/2021 via UPS 2-day delivery. The consignee is requested to: -Review the VenaSeal Gun Assist Process as provided in Appendix A. -Please share this information with any other healthcare professionals in their facility who use the VenaSeal Closure System. Also share this information with any other organization where these devices may have been transferred. -Maintain a copy of this letter for the consignee's reference. -Please complete the enclosed Customer Confirmation Form and return via email [email protected] -Please notify Medtronic of any adverse events or quality problems associated with use of this product. -Complete and submit the report Online: www.fda.gov/medwatch/report.htm -Regular Mail or Fax: Download form www.fda.gov/MedWatch/getformstm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178 In other geographies, communication of the Medical Device Correction letter began on 23-Mar-2021, via regionally approved methods. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification.

    Distribution

    Distributed nationwide to MA, NY, VT, NH, ME

    Quantity

    154,152 units