Events

Recall of AMS 800 Artificial Urinary Sphincter Control PumpsItem numbers (REF): 72400098 and 72404127

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by American Medical Systems Australia Pty Ltd.

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
    RC-2013-RN-00230-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00230-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Investigations undertaken in response to customer complaints have found that selected lots of two models of control pumps supplied in australia were released despite not fully meeting the manufacturer's product release criteria.
  • Action
    AMS is advising that the risk of prophylactic removal of implanted control pumps outweighs any benefit. Physicians are requested to review the information in the Hazard Alert and use normal clinical practice to determine necessary actions. for more details, please see http://www.tga.gov.au/safety/alerts-device-ams800-controlpump-130326.htm .

Device

AMS 800 Artificial Urinary Sphincter Control PumpsItem numbers (REF): 72400098 and 72404127

Manufacturer

American Medical Systems Australia Pty Ltd
  • Source
    DHTGA