Device Recall Pathway Balloon Expandable Ureteral Access Sheath 13/16/36

  • Model / Serial
    Lot numbers: W03-1482, W03-1491, W03-1508, W03-1524, W03-1740, W03-1917, W03-2107, W03-2113, W03-2214, W03-2216, W03-2236, W03-2239, W03-2240, W03-2285, W03-2354, W03-2410, W03-2446, W03-2457, W03-2483, W03-2580
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760
  • 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