BEUDAMED
    FDA Recall Open, Classified

    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J

    Recall: Z-2945-2024 · Initiated July 1, 2024

    Recall

    Recall Number
    Z-2945-2024
    Event Number
    94971
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    PRL
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    July 1, 2024
    Posted
    August 30, 2024
    Address
    3750 W Kiltie Ln, Flagstaff, AZ, 86005-8712

    Description

    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J

    Reason

    Due to packaging defects, sterility assurance and heparin activity may be compromised.

    Action

    Between the dates of July 18-19,2024 , W.L. Gore issued a "Urgent Medical Device Correction" notification to affected consignees either via UPS or hand delivery. W.L. Gore asked consignees to take the following actions: 1. For US Only, per the IFU, carefully inspect the foil pouch to ensure that it is not compromised. Do not use the GORE VIABAHN VBX Balloon Expandable Endoprosthesis if the foil pouch is compromised. Do not use the GORE VIABAHN VBX Balloon Expandable Endoprosthesis if the sterile pouch is compromised. This warning includes the Compliance Chart embedded in the seal or a damaged/cut Compliance Chart. 2. Open the foil pouch, and gently remove the coil containing the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis and the Compliance Chart. Carefully inspect the Compliance Chart to ensure that it is not damaged. Do not use the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis if the Compliance Chart cannot be removed from the pouch or is damaged as the Compliance Chart may have been embedded in the seal. Reference sample images below. 3. Implanting Physicians: If you suspect you have implanted a potentially compromised Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis device, please be mindful of the potential health outcomes and plan to take the needed measures that could minimize any potential health hazard/risk/harms associated with a compromised sterile barrier. 4. Please complete and sign the enclosed ACKNOWLEDGEMENT FORM and return to [email protected] within 2 weeks of receipt of this notification. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). On 10/25/24, additional correction notices were sent to customers informing them that additional devices were found to be affected.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.

    Quantity

    42,901 units