Devices

Device Recall Boston Scientific

  • Modèle / numéro de série
    Lot Numbers: 7991049, 8056668, 8263142, 8502337, 8502338, 8521621, 8628863, 8770896, 8829555, 8909937
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
  • Description du dispositif
    Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Fabricant

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA

174 dispositifs médicaux avec un nom similaire

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Device Recall Boston Scientific Scimed Express II
  • Modèle / numéro de série
    Lot 5570485
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    The products were shipped to consignees located nationwide in the United States.
  • Description du dispositif
    Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
  • Manufacturer
    Boston Scientific Scimed
Device Recall Boston Scientific Scimed
  • Modèle / numéro de série
    Lot 5689062
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled products were distributed to consignees located nationwide in the United States.
  • Description du dispositif
    Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
  • Manufacturer
    Boston Scientific Scimed
Device Recall Boston Scientific Scimed
  • Modèle / numéro de série
    Lots 5685024 and 5685027
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled products were distributed to consignees located nationwide in the United States.
  • Description du dispositif
    Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
  • Manufacturer
    Boston Scientific Scimed
Device Recall Boston Scientific Scimed
  • Modèle / numéro de série
    Lot 5707453
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled products were distributed to consignees located nationwide in the United States.
  • Description du dispositif
    Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
  • Manufacturer
    Boston Scientific Scimed
Device Recall Boston Scientific Constellation Advanced Mapping Catheter
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    This product was distributed to 521 accounts worldwide.
  • Description du dispositif
    Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
  • Manufacturer
    Boston Scientific
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