Events

Recall of Device Recall Boston Scientific/Microvasive

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
    25812
  • Event Risk Class
    Class 2
  • Event Number
    Z-0736-03
  • Event Initiated Date
    2003-03-17
  • Event Date Posted
    2003-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26513
  • 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
    Catheter, Urethral - Product Code GBM
  • Reason
    Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use.
  • Action
    Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.

Device

Device Recall Boston Scientific/Microvasive
  • Model / Serial
    Lot Numbers: 5225786 5303820 5312170 5340602
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
  • Product Description
    Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) || Product Number: 400-203
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Place, Natick MA 01760
  • Source
    USFDA