BEUDAMED
    FDA Recall Open, Classified

    Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1

    Recall: Z-1268-2022 · Initiated April 12, 2022

    Recall

    Recall Number
    Z-1268-2022
    Event Number
    90085
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    LWS
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 12, 2022
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1

    Reason

    Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

    Action

    A Recall notification was sent to the consignees on 04/12/2022 via the United Parcel Service. The letter instructs the consignee to continue normal follow-up frequency per local clinic protocol and for the consignee to submit the response form.

    Distribution

    Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and internationally to Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Canary Islands, Chile, Croatia, Czech Republic, Denmark, Egypt, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Greece, Greenland, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kuwait, Liechtenstein, Luxembourg, Malaysia, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom, United States, Uruguay, Australia , Korea, Panama, South Korea

    Quantity

    3944 units