Device Recall Boston Scientific Clipping Device, Resolution Clip

  • Model / Serial
    Product code M00522610, lots 0ML9042004, 0ML9042101, 0ML9042102, 0ML9042702, 0ML9050401 and 0ML9051201. Product code M00522612, lots 0ML9042005, 0ML9042006, 0ML9042204, 0ML9042705, 0ML9042706, 0ML9050402, 0ML9050403, 0ML9051205 and 0ML9051206.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.
  • Product Description
    Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522610 (1 clip) and M00522612 (20 clips). || The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Corporation, 500 Commander Shea Blvd, Quincy MA 02171-1518
  • 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Product code M00522600, lot 0ML9042402 and Product code M00522602, lot 0ML9042701.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.
  • Product Description
    Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips). || The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.
  • Manufacturer