Events

Recall of Device Recall AMS Her Option Cryoablation Therapy Disposable Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Medical Systems.

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
    34426
  • Event Risk Class
    Class 2
  • Event Number
    Z-0675-06
  • Event Initiated Date
    2006-01-13
  • Event Date Posted
    2006-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43820
  • 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
    Device, Thermal Ablation, Endometrial - Product Code MNB
  • Reason
    Overheating of the cryoablation therapy disposable probe (cu-1), could cause a burn injury to a patient or user in certain circumstances.
  • Action
    An Urgent Device Recall / Product Safety Advisory letter, dated January 25, 2006, was sent to all customers who have purchased Disposable Probes since 01/01/2005 or who have in their possession a Her Option console (whether customer owned or AMS owned). The letter informs customers of the issue and of the 2 lots being recalled. The letter also includes Safety Advisory Instruction which are to be posted on or near the Her Option Console. A Recall Acknowledgement Form is asked to be returned to American Medical Systems which serves as an indication that the customer read the notice, is returning affected product and have understood and posted the Safety Advisory instructions.

Device

Device Recall AMS Her Option Cryoablation Therapy Disposable Probe
  • Model / Serial
    Lots 431803 & 436666
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide. AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI
  • Product Description
    her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.
  • Manufacturer
    American Medical Systems

Manufacturer

American Medical Systems
  • Manufacturer Address
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA