Devices

Device Recall Angeion Sentinel ICD

  • Modelo / Serial
    BE650129, BE650026 and BE650027. OUS: BE650038 and BE650002
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
  • Descripción del producto
    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
  • Manufacturer
    ela Medical Llc
  • 1 Event

Fabricante

ela Medical Llc
  • Dirección del fabricante
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA

Dispositivo con un nombre similar

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Device Recall Angeion Sentinel ICD
  • Modelo / Serial
    AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099, AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102, AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197, AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146 OUS codes:AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069, AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111, AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186, AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283, AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
  • Descripción del producto
    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
  • Manufacturer
    ela Medical Llc