Device Recall Boston Scientific

  • Model / Serial
    Lot Numbers: 8984691, 9005322, 9005726, 9005727
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Sweden, and South Africa.
  • Product Description
    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 || UPN Number: M00513331 || REF: 1333-20
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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 devices with a similar name

Learn more about the data here

  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    Catalog No. 38950-01J0, Box Lot No. AND Inner-Pouch Lot/Batch #: 8435441/8416147, 8445221/8395559, 8456936/8422573.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / 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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    Catalog No. 38951-010, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423358/8387074, 8453483/8432572, 8464007/8432571, 8510637/8404526.  Catalog No. 38951-012, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423360/8387074, 84640088432571, 8510638/8404526.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38951-012, 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
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