BEUDAMED
    FDA Recall Open, Classified

    Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1

    Recall: Z-1490-2022 · Initiated June 22, 2022

    Recall

    Recall Number
    Z-1490-2022
    Event Number
    90565
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    NIK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 22, 2022
    Posted
    August 9, 2022
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1

    Reason

    There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

    Action

    Beginning 22-JUN-2022 communications to all affected consignees began. In the United States notifications are sent via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification. Consignees are asked to quarantine the subset of unused identified Cobalt and Crome devices for retrieval due to potential manufacturing non-conformance and return the inventory to Medtronic. On approximately 08/10/2022, Medtronic notified Risk Managers of the availability of a SW update and actions specific to update the SW on the SmartSync devices, that will in turn update the patient's implanted device during their next clinic visit. In addition, on this same date, a separate communication dated August 2022 is being sent to all affected Implanting Physicians notifying them that a SW update is available and recommended actions to correct this issue with their patient's implanted device. The second notification to physicians did not request returned confirmation.

    Distribution

    Worldwide Distribution

    Quantity

    866 units