Events

Recall of SureSight Obturator Introducer Localization Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    74839
  • Event Risk Class
    Class 2
  • Event Number
    Z-2765-2016
  • Event Initiated Date
    2016-08-02
  • Event Date Posted
    2016-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148566
  • 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
    Guide, needle, surgical - Product Code GDF
  • Reason
    Tip breakage at the glue joint between the obturator body and tip.
  • Action
    Hologic sent an Important Product Recall letter to customers in the United States through Certified letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory and cease use of all affected recalled product. Customers were asked to complete the enclosed Recall Response Card indicating whether you have any of the recalled product on hand, as well as the quantity of product that you have in stock.

Device

SureSight Obturator Introducer Localization Systems
  • Model / Serial
    Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. || ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece || Product Usage: || The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator
  • Manufacturer
    Hologic, Inc

Manufacturer

Hologic, Inc
  • Manufacturer Address
    Hologic, Inc, 250 Campus Dr, Marlborough MA 01752-3020
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA