BEUDAMED
    FDA Recall Open, Classified

    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

    Recall: Z-2340-2021 · Initiated July 12, 2021

    Recall

    Recall Number
    Z-2340-2021
    Event Number
    88331
    Firm
    W. L. Gore & Associates Inc.
    FEI Number
    3007284313
    Product Code
    MJN
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    July 12, 2021
    Address
    32360 N North Valley Pkwy, Phoenix, AZ, 85085-4228

    Description

    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

    Reason

    Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.

    Action

    On July 23, 2021 issue a "Urgent Medical Device Recall" notification to affected consignees via UPS. In addition to informing consignees about the recall the customer notification ask consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to [email protected] within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. 4. If a listed device has been used, there is no patient-follow up needed and there are no further actions needed other than informing Gore the device was used. Please indicate the used devices on the CUSTOMER RESPONSE FORM and return to [email protected] within 2 weeks of receipt of this letter. No further action is needed.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.

    Quantity

    3,364 units