BEUDAMED
    FDA Recall Open, Classified

    Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

    Recall: Z-2192-2024 · Initiated April 16, 2024

    Recall

    Recall Number
    Z-2192-2024
    Event Number
    94674
    Firm
    Medtronic Inc.
    FEI Number
    2182208
    Product Code
    NIK
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 16, 2024
    Posted
    June 26, 2024
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

    Reason

    Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

    Action

    On about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

    Quantity

    14 units