Events

Recall of AngioJet Ultra 5000A Console - Foot Switch

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific 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-2017-RN-00183-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00183-1
  • 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
    There have been reports regarding the angiojet ultra 5000a console foot switch sticking during use resulting in an undesired continued operation of the device. this situation can occur as a result of the wear and tear of the foot switch, which is normally captured through routine servicing. the most serious consequence from this issue could be the need to abort a procedure if the situation has not been resolved and alternative options are not available. at this stage, there have been no reported patient adverse events as a result of these complaints.
  • Action
    Users are advised that if the situation occurs during use, perform the troubleshooting steps per the operator’s manual. An attempt can be made to manually release the footswitch, or turn the console off to deactivate the catheter. Boston Scientific is advising users who have this issue to discontinue use of the AngioJet Ultra 5000A Console foot switch and to contact their local sales representative. No action is required by users whose device is operating correctly.

Device

AngioJet Ultra 5000A Console - Foot Switch

Manufacturer

Boston Scientific Pty Ltd
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA