Events

Recall of Device Recall Pathway Balloon Expandable Ureteral Access Sheath 12/15/36

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46330
  • Event Risk Class
    Class 2
  • Event Number
    Z-0912-2008
  • Event Initiated Date
    2007-11-30
  • Event Date Posted
    2008-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67194
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ureteral dilator - Product Code EZN
  • Reason
    Sheath removal difficulty: users experience difficulty in removing the sheath.
  • Action
    Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007. The letter instructed users to check their inventory, remove any affected product and place them in quarantine. It also included instructions for returning the product. Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form.

Device

Device Recall Pathway Balloon Expandable Ureteral Access Sheath 12/15/36
  • Model / Serial
    Lot numbers: W03-2339, W03-2342, W03-2362, W03-2382, W03-2409, W03-2431, W03-2434, W03-2436, W03-2439, W03-2479, W03-2482, W03-2550, W03-2555, W03-2581, W03-2591
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 500 Commander Shea Blvd, Quincy MA 02171-1518
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • 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