Device Recall Boston Scientific IQ Guide Wire

  • 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA

3 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