Events

Recall of Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2016-RN-00772-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-06-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00772-1
  • 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
    Stryker neurovascular has become aware that some units of the target nano detachable coils do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.The most likely adverse health consequence from coil stretching is prolongation of the procedure, as the stretched coil needs to be removed from the patient and replaced. there is a potential of thrombus formation when the stretched coil is left exposed in the blood flow. additional intervention may be required to snare the stretched coil or pin it to the vessel wall with a stent if safe removal is not possible. this may result in thrombus or thromboembolism which can lead to stroke. there will be no long term adverse health consequence after a stretched coil is removed from the body.
  • Action
    Stryker is advising users to inspect stock and quarantine any remaining affected units for return. This action has been closed-out on 03/03/2017.

Device

Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)
  • Model / Serial
    Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)Item Numbers: 542102, 542103, 542152, 542153, 542154, 543101, 543102, 543103, 543151, 543152, 543153, 543154, 544203, 544204, 544254, 544304, 544306, 544356, 545202, 545203, 545204, 545206, 545253, 545254, 545256, 545304, 545306, 545308Multiple lot numbers affectedARTG Number: 170214
  • Product Classification
    Neurological Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA