Events

Recall of Device Recall Stonetome

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
    35535
  • Event Risk Class
    Class 2
  • Event Number
    Z-1109-06
  • Event Initiated Date
    2006-05-19
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46343
  • 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
    Dislodger, Stone, Biliary - Product Code LQR
  • Reason
    Lack of assurance of sterility, as the sterile barrier may fail.
  • Action
    Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.

Device

Device Recall Stonetome
  • Model / Serial
    All lots. Lots 588218, 7173503, 7907512, 8541152, 6553517, 7209058, 7923845, 8541153, 6573307, 7213538, 7938899, 6593724, 7238048, 7959199, 6628839, 7244918, 7978741, 6650500, 7312261, 7988003, 6663230, 7323058, 8012669, 6684869, 7345074, 8037031, 6684870, 7368731, 8056507, 6710850, 7394062, 8076206, 6731508, 7416357, 8076207, 6745329, 7441769, 8093643, 6762317, 7469187, 8115498, 6783937, 7487245, 8131913, 6798010, 7510076, 8146780, 6811675, 7536508, 8154851, 6832811, 7550048, 8165619, 6834085, 7570081, 8194623, 6843046, 7592340, 8221047, 6870688, 7613897, 8250992, 6893879, 7635034, 8262323, 6896571, 7635532, 8272381, 6917737, 7656406, 8301236, 6919072, 7701169, 8303922, 6939764, 7722952, 8304044, 6946002, 7738501, 8304054, 6965093, 7738922, 8326168, 6979350, 7773671, 8331426, 6988355, 7794744, 8337750, 7005425, 7813723, 8359941, 7037237, 7833511, 8378721, 7049995, 7833512, 8393169, 7052629, 7845564, 8414769, 7076211, 7845565, 8428051, 7096493, 7864321, 8444985, 7121618, 7891878, 8461221, 7143069, 7892977, 8489777, 7163174, 7900869 and 8509967.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

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