BEUDAMED
    FDA Recall Open, Classified

    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

    Recall: Z-0202-2019 · Initiated June 20, 2018

    Recall

    Recall Number
    Z-0202-2019
    Event Number
    80501
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    OAD
    Status
    Open, Classified
    Initiated
    June 20, 2018
    Posted
    August 28, 2018
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

    Reason

    Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

    Action

    On 06/20/2018, a system notice was sent to customers, informing them that releasing the foot switch may not stop RF delivery. If RF delivery does not stop as intended, press and release the RF Power Control button. Customers were advised to report occurrence and clinical outcome of unintended RF delivery to the firm:United States (1-800-949-6708), Europe, Middle East, and Africa (+800-5555-7707), Asia Pacific (+65-6418-8878). Notification outside of the U.S. started 06/21/18. On 09/20/2019, a System Correction Notice was sent to Cath/EP Lab Managers informing them that the firm will begin the process of upgrading the firmware of affected cardiac ablation systems. The firmware update will eliminate one potential cause of this behavior. Residual risks for other potential causes of RF termination delay remain. Cath/EP Lab Managers were asked to distribute the notice within their respective facilities, continue to post a copy of Appendix A of the June 2018 notice near each affected system, allow the recalling firm to access affected systems for the firmware update, and to complete, sign, and return the acknowledgement form.

    Distribution

    U.S.: PA, IL, NY, CA, SC, AR, SD, AZ, KY, FL, TX, MA, MI, OH, LA, VA, NC, WA, DE, IN, TN, NJ, CT, AL, ME, GA, NH, MN, MD, DC, OK, HI, WI, CO, MO, IA, GU, NE, OR, ID, UT, RI, KS, NV, MS, WV Foreign (OUS): Canada, Albania, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Lithuania, Namibia, Netherlands, Lebanon, Pakistan, Poland, Portugal, Russian Fed., Saudi Arabia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Unit.Arab Emir., Argentina, Australia, Bangladesh, Chile, China, Colombia, Japan, Malaysia, Mexico, Nicaragua, Panama, Philippines, Sri Lanka, Taiwan, Thailand, Vietnam

    Quantity

    793