Device Recall Boston Scientific

Fabricante

  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA

174 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model numbers 8031, 8038, 8048, 8060, 8075. 510(k) numbers K983171, K992777, K000277, K021232, K003782. Product Code DXQ. Product UPN numbers: Domestic: Constellation 31 mm/2mm: M004 US8031 0, M004 US8031 L0, M004 US8031 M0. 38mm/3mm: M004US8038 0, 4004 US8038 L0, M004 US8038P0. 48MM/4MM M004 US8048 0, M004 US8048B0, M004 US8048P0. 60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0. 75mm/7mm: M004 US0875 0, M004 US0875B0, M004 US8075P0.   Outside of US product: Constellation 31 mm/2mm: M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0. 38mm/3mm: M004EPT8038 0, 4004 EPT8038 L0, M004 EPT8038P0. 48MM/4MM M004 EPT8048 0, M004 EPT8048B0, M004 EPT8048P0. 60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0. 75mm/7mm: M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    This product was distributed to 521 accounts worldwide.
  • Descripción del producto
    Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 7355316 7382682 7401867
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
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  • Modelo / Serial
    Lot Numbers:  6851116 6854849 7042710  7088274 7196763
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
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    Banana Peel™ Sheaths BP/12/15 || Catalog Number: 20-608
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    Lot Numbers:   6366302 6388114 6412027 6436181 6444376 6458141 6480766 6484535 6523598 6537720 6560008 6585320 6599016 6620743 6670299 6722845 6765615 6779675 6793496 6835091 7552029 7569737 7592927 7619448
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  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
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    Banana Peel™ Sheaths BP/9/15 || Catalog Number: 20-606
  • Manufacturer
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