BEUDAMED
    FDA Recall Terminated

    IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.

    Recall: Z-1705-2019 · Initiated May 14, 2019

    Recall

    Recall Number
    Z-1705-2019
    Event Number
    82870
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DXC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 14, 2019
    Posted
    June 11, 2019
    Terminated
    April 23, 2024
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.

    Reason

    Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

    Action

    On 05/14/19, the firm, Edwards, mailed "Urgent Product Recall" notices, via overnight service to its customers. The letter described the product, problem and actions to be taken. The letter informed customers of the recall and instructed them to do the following: 1) Review this field safety notice to understand the potential hazard. 2) Complete and return the attached Acknowledgement Form within five (5) business days of receiving this notice to Customer Service. 3) Complete and return the Product Reconciliation Form to Customer Service; return affected devices with the Return Goods Authorization (RGA) provided. 4) Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. If you have further distributed this product, notify your customers to the user level. Report any balloon failures to the recalling firm. Customers with additional questions were encouraged to call Customer Service Monday through Friday at (800) 424-3278, Option 1, from 8:00 AM - 4:00 PM Pacific Time. On 07/09/19, Urgent Product Recall notices were mailed via next-day service to customers informing them of the recall expansion.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: UT, GA, NJ, CA, OH, PA, AL, FL, TN, TX, ME, MA, IN, MS, NY, VA, MI, IL, CO, OR, WA, SC, AZ, SD, MO, CT, OK, NV, WV, WI, NC, MN, KY; and countries of: United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, France, United Kingdom, Italy, Netherlands, Poland, Romania, and Sweden.

    Quantity

    6552