Events

Recall of Boston Scientific TruPath Biopsy Systems

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

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
    50087
  • Event Risk Class
    Class 3
  • Event Number
    Z-0495-2009
  • Event Initiated Date
    2008-10-17
  • Event Date Posted
    2009-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74707
  • 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
    kit, needle, biopsy - Product Code FCG
  • Reason
    These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
  • Action
    U.S. consignees were notified via letter dated 10/17/08, which informs them of the problem, instructs them to remove from use and quarantine the recalled lots and requests completion and submission of the Reply Verification Tracking form via fax at 508-683-5578. For questions about this recall, contact your local Boston Scientific representative.

Device

Boston Scientific TruPath Biopsy Systems
  • Model / Serial
    Lot 0011537463.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
  • Product Description
    Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 1215, REF M00512150 and M00512151. || For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA