BEUDAMED
    FDA Recall Open, Classified

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    Recall: Z-1692-2024 · Initiated March 1, 2024

    Recall

    Recall Number
    Z-1692-2024
    Event Number
    94232
    Firm
    Thoratec Corp.
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 1, 2024
    Posted
    May 1, 2024
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    Description

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    Reason

    Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

    Action

    On March 20, 2024, Abbott issued a Urgent: Medical Device Correction Notification to affected consignee via E-Mail. Abbott asked consignees to take the following actions: 1. The product is not being removed from the field and unused product does not need to be returned. 2. If blood leak or air entrainment is suspected or observed, follow standard surgical processes and the existing IFU: 2a. Residual air must be completely evacuated from the device blood chamber prior to initiating the LVAD support. 2b.Ensure that bleeding is assessed and ensure proper management of hemostasis before closing all wounds. 2c. Use conventional strategies for resolving air leaks or surgical bleeding, including: adjusting the pump position, waiting for the natural tendency of blood to coagulate or upon reversal of anticoagulation, adding surgical materials, and exchanging the apical cuff, the pump, or both. 2d. Always have a complete backup system (implant kit and external components) available on-site and in close proximity during the implantation procedure for use in the event of an emergency. 3. Please distribute this notice to those who need to be aware within your institution and complete the attached acknowledgment form included with this letter and return it to Abbott at email: [email protected]. Should you have any questions about this communication, please contact your local Abbott representative or call 612-346-3514.

    Distribution

    Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WV; and OUS (foreign) countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, and Uzbekistan.

    Quantity

    882 units