BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2192-2024 · Reported July 3, 2024

    Enforcement

    Recall Number
    Z-2192-2024
    Event ID
    94674
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 3, 2024
    Initiation Date
    April 16, 2024
    Classification Date
    June 26, 2024
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States

    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.

    Code Info

    GTIN: 00763000178130, Serial Numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504S, RTG612505S, RTG612509S, RTG612512S, RTG612513S, RTG612549S, RTG612553S, RTG612556S.

    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