BEUDAMED
    FDA Recall Open, Classified

    Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.

    Recall: Z-2212-2024 · Initiated April 16, 2024

    Recall

    Recall Number
    Z-2212-2024
    Event Number
    94674
    Firm
    Medtronic Inc.
    FEI Number
    2182208
    Product Code
    LWS
    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

    Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.

    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

    82 units