Events

Recall of Boston Scientific

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
    33993
  • Event Risk Class
    Class 2
  • Event Number
    Z-0259-06
  • Event Initiated Date
    2005-10-25
  • Event Date Posted
    2005-12-01
  • 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=42864
  • 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
    Retractor - Product Code GAD
  • Reason
    Sterility of device compromised due to breach in packaging.
  • Action
    Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.

Device

Boston Scientific
  • Model / Serial
    All lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) || Product Code: 820-123
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA