Device Recall Boston Scientific

  • Model / Serial
    Lot Numbers: 8984687, 8984688, 8984689, 8990186, 9003394, 9003396, 9005718, 9005719, 9017283
  • 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 40 || UPN Number: M00513332 || REF: 1333-40
  • 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
    Lot Numbers: 7355316 7382682 7401867
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
  • Product Description
    Banana Peel™ Sheaths BP/11/15 || Catalog Number: 20-607
  • Manufacturer
  • Model / Serial
    Lot Numbers:  6851116 6854849 7042710  7088274 7196763
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
  • Product Description
    Banana Peel™ Sheaths BP/12/15 || Catalog Number: 20-608
  • Manufacturer
  • Model / Serial
    Lot Numbers:   6366302 6388114 6412027 6436181 6444376 6458141 6480766 6484535 6523598 6537720 6560008 6585320 6599016 6620743 6670299 6722845 6765615 6779675 6793496 6835091 7552029 7569737 7592927 7619448
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
  • Product Description
    Banana Peel™ Sheaths BP/9/15 || Catalog Number: 20-606
  • Manufacturer
  • Model / Serial
    Lot Numbers:  6823847 6837612 6854851 6887568 6896412 6956415 7124100 7172813 7196765 7235401 7330324 7355512 7382529 7401694 7401860 7456768 7472843 7495201 7514119
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
  • Product Description
    Banana Peel™ Sheaths BP/16/15 || Catalog NUmber : 20-610
  • Manufacturer
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