BEUDAMED
    FDA Recall Open, Classified

    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L

    Recall: Z-0201-2023 · Initiated September 28, 2022

    Recall

    Recall Number
    Z-0201-2023
    Event Number
    90892
    FEI Number
    1219930
    Product Code
    GAM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 28, 2022
    Posted
    November 11, 2022
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L

    Reason

    Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

    Action

    Beginning 28-September-2022 communications to all affected consignees began. Consignees are asked to return any affected product they may have, forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Canada Canary Islands Chile Croatia Cyprus Denmark Egypt Finland France Germany Greece Hungary Ireland Israel Italy Jordan Kazakhstan Kuwait Lithuania Luxembourg Mexico Netherlands New Zealand Norway Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom

    Quantity

    30658