BEUDAMED
    FDA Recall Open, Classified

    Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

    Recall: Z-2658-2023 · Initiated August 7, 2023

    Recall

    Recall Number
    Z-2658-2023
    Event Number
    92951
    Firm
    Thoratec Corp.
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 7, 2023
    Posted
    September 29, 2023
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    Description

    Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

    Reason

    Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

    Action

    On 8/7/23 customers were notified of the recall verbally, via email, in person visits, and phone calls. 8/21/23 the Abbott sales representatives started hand delivering correction notices to customers were told the firm was reinforcing the following warning in the Instructions for Use: 1) During the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in the event of an emergency. 2) Additionally, if unusual resistance is encountered during the coring procedure, immediately stop coring and complete using the backup Apical Coring Knife. Customers were also informed that in cases were the recall issue occurred during use, the physician was able to complete the procedure by using an Apical Coring Knife from the backup LVAS implant kit or an alternate surgical tool. Distribute this notice to those who need to be aware within your institution. Firm is continuing its investigation on this matter and working diligently to resume normal supply. Direct questions to your local Abbott representative. Complete and return the acknowledgement form via email to [email protected] Correction notices are continuing to be distributed identifying additional affected serial numbers. The firm is continuing to work with the apical coring knife vendor to supply knives that do not present this issue. However, the supply of unaffected apical coring knives continues to be limited.

    Distribution

    Worldwide - US Nationwide distribution including in the states of 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 the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia , Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    2,681