BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported July 3, 2024

    Enforcement

    Recall Number
    Z-2212-2024
    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

    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.

    Code Info

    a. GTIN: 00763000612269, Serial Numbers: BLG628370S, BLG628372S, BLG628373S. b. GTIN: 00763000206284, Serial Number: RPO606047S. c. GTIN: 00763000206222, Serial Numbers: RPB629895S, RPB629900S, RPB629902S, RPB629906S, RPB629909S, RPB629912S. d. GTIN: 00763000206307, Serial Number: RPQ610208S. e. GTIN: 00763000206291, Serial Numbers: RPK614721S, RPK614728S. f. GTIN: 00763000206253, Serial Numbers: RPP607499S, RPP607504S, RPP607517S, RPP607518S, RPP607522S, RPP607586S. g. GTIN: 00763000206246, Serial Numbers: RPG643295S, RPG643318S; GTIN 00763000611835, Serial Numbers: RPG643198S, RPG643199S, RPG643200S, RPG643203S, RPG643206S, RPG643209S, RPG643211S, RPG643213S, RPG643218S, RPG643219S, RPG643220S, RPG643221S, RPG643231S, RPG643251S. h. GTIN: 00763000206260, Serial Numbers: RPF648668S, RPF648672S, RPF648674S, RPF648675S, RPF648676S, RPF648677S, RPF648681S, RPF648684S, RPF648685S, RPF648686S, RPF648691S, RPF648693S, RPF648702S, RPF648758S, RPF648760S, RPF648761S, RPF648762S, RPF648763S, RPF648768S, RPF648769S, RPF648770S, RPF648771S, RPF648844S, RPF648846S, RPF648847S. i. GTIN: 00763000206147, Serial Numbers: PGZ663023S, PGZ663203S, PGZ663208S, PGZ663211S, PGZ663216S, PGZ663219S, PGZ663241S, PGZ663264S. j. GTIN: 00763000612191, Serial Numbers: CWH606546S, CWH606548S, CWH606551S, CWH606552S, CWH606553S. k. GTIN: 00763000206352, Serial Numbers: PMX622050S, PMX622052S, PMX622055S, PMX622056S, PMX622057S, PMX622059S. l. GTIN: 00763000206338, Serial Numbers: PLX622054S, PLX622056S, PLX622072S.

    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