Device Recall Boston Scientific Scimed

  • Model / Serial
    Lot numbers 5490680, 5540265, and 5584469
  • Product Classification
  • Distribution
    The recalled products were shipped to hospitals located nationwide in the United States.
  • Product Description
    Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Scimed, One Scimed Place, Maple Grove MN 55311-1566
  • Source
    USFDA

32 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot number 5140999
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
  • Product Description
    Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
  • Manufacturer
  • Model / Serial
    Lot number 5350420
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide in the United States
  • Product Description
    Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400
  • Manufacturer
  • Model / Serial
    Lot number 5357125
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide in the United States
  • Product Description
    Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301
  • Manufacturer
  • Model / Serial
    Lot number 5350197
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide in the United States
  • Product Description
    Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401
  • Manufacturer
  • Model / Serial
    Lot numbers 5490976, 5530109, and 5564475
  • Product Classification
  • Distribution
    The recalled products were shipped to hospitals located nationwide in the United States.
  • Product Description
    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015
  • Manufacturer
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