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
    Catalog number 19500-448, Lot # 655713; Catalog number 19500-498, Lot # 655721; Catalog number 19500-08, Lot # 657310; Catalog number 19500-09, Lot # 657311; Catalog number 19500-132, Lot # 655680; Catalog number 19500-27, Lot # 655695;
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA.
  • Descripción del producto
    Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
  • Manufacturer
  • Modelo / Serial
    Catalog No. 38950-02J0, Box Lot No. AND Inner-Pouch Lot/Batch #: 8455558/8427510, 8478045/8427509.  Catalog No. 38950-02J2, Box Lot No. AND Inner-Pouch Lot/Batch #: 8455560/8427510, 8478046/8427509.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.
  • Descripción del producto
    Boston Scientific IQ Guide Wire. Catalog No. 38950-02J0, 300 cm, J-Tip, Single Pack. Catalog No. 38950-02J2, 300 cm, J-Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
  • Manufacturer
  • Modelo / Serial
    Catalog No. 38950-010 with Box Lot/Batch No. AND Inner-Pouch Lot/Batch No.: 8396722/8374308, 8397332/8374309, 8411208/8387184, 8414011/8398030, 8414321/8391628, 8414625/8394866, 8414627/8395261, 8414958/8391724, 8423202/8404318, 8423636/8398031, 8428184/8408727, 8430959/8404322, 8433309/8408726, 8433399/8403092, 8435627/8415782, 8437126/8415778, 8438614/8413997, 8439171/8419527, 8439179/8419528, 8440181/8419529.   Catalog No. 38950-012 with Box Lot No. AND Inner-Pouch Lot/Batch No.: 8396863/8374308, 8397333/8374309, 8411209/8387184, 8414012/8398030, 8414319/8391628, 8414626/8394866, 8414628/8395261, 8414957/8391724, 8423343/8404318, 8423638/8398031, 8428185/8408727, 8430961/8404322, 8433308/8408726, 84333938403093, 8433400/4803092, 8435628/8415782, 8437125/8415778, 8438615/8413997, 8439172/8419527, 8439180/8419528, 8440182/8419529.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.
  • Descripción del producto
    Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
  • Manufacturer
  • Modelo / Serial
    Catalog No. 38950-01J0, Box Lot No. AND Inner-Pouch Lot/Batch #: 8435441/8416147, 8445221/8395559, 8456936/8422573.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.
  • Descripción del producto
    Boston Scientific IQ Guide Wire. Catalog No. 38950-01J0, 185 cm, J-Tip, Single Pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
  • Manufacturer
  • Modelo / Serial
    Catalog No. 38950-020, Box Lot No. AND Inner-Pouch Lot/Batch #: 8454288/8428973.  Catalog No. 38950-022, Box Lot No. AND Inner-Pouch Lot/Batch #: 8454289/8428973, 8474720/8428974
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.
  • Descripción del producto
    Boston Scientific IQ Guide Wire. Catalog No. 38950-020, 300 cm, Straight Tip, Single Pack. Catalog No. 38950-022, 300 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
  • Manufacturer
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