Events

Recall of Device Recall Boston Scientific HTA Thermal endometrial ablation system

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
    37291
  • Event Risk Class
    Class 2
  • Event Number
    Z-0690-2007
  • Event Initiated Date
    2007-01-24
  • Event Date Posted
    2007-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50296
  • 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
    Thermal endometrial ablation system - Product Code MNB
  • Reason
    Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree c into uterus) if in use during the recirculation/heating phase of treatment.
  • Action
    Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.

Device

Device Recall Boston Scientific HTA Thermal endometrial ablation system
  • Model / Serial
    Unit Numbers: IN0350JG, IN0351JG,
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, UK, Denmark, Italy, and France
  • Product Description
    HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760-1536
  • Source
    USFDA