Events

Recall of ATEC BREAST BIOPSY & EXCISION SYSTEM -INTRODUCER LOCALIZATION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOLOGIC INC..

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
    146730
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    There have been reports that the localizing obturator is breaking before and during procedures at the glue joint between the body and the tip. these breakages in the field may result in harm to the patient and the need for additional intervention to remove the broken product from the patient.

Device

ATEC BREAST BIOPSY & EXCISION SYSTEM -INTRODUCER LOCALIZATION SET
  • Model / Serial
    Model Catalog: ILS-0914-12-OB (Lot serial: >10 contact MFG); Model Catalog: ILS-0914-20-OB (Lot serial: >10 contact MFG)
  • Product Description
    SureSight Obturator - Introducer Localization System
  • Manufacturer
    HOLOGIC INC.

Manufacturer

HOLOGIC INC.
  • Manufacturer Address
    MARLBOROUGH
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC