BEUDAMED
    FDA Recall Terminated

    Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

    Recall: Z-0845-2019 · Initiated January 17, 2019

    Recall

    Recall Number
    Z-0845-2019
    Event Number
    81950
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    OSR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 17, 2019
    Terminated
    March 30, 2021
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

    Reason

    There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.

    Action

    In the US, beginning 17-Jan-2019, Medtronic Field Representatives (Field Reps) will locate all Encore programmers both in their trunk stock and in consignment locations. Since the Encore Power Supplies are interchangeable among all Encores, all Encore programmer distributed units are being located, and the associated Power Supplies will be checked to identify any affected units. If the Field Rep identifies an affected Power Supply physically at a customer account, the Medtronic Field Rep will hand deliver a courtesy FCA Notification Letter with instructions to the Risk Manager or HealthCare Professional at the account.

    Distribution

    US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic

    Quantity

    731 units