Events

Recall of STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet 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-00697-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00697-1
  • 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
    During post-quarantine packaging it was identified that the ifu for the statlock sheath stabilisation device for percutaneous sheath introducers was erroneously packaged with the mega and sensation plus iab catheter kits, instead of the ifu for the statlock catheter stabilisation device for iab catheters.
  • Action
    Maquet is advising users to inspect and identify the affected stocks. The IFU from the affected units should be removed and disposed prior to the use of the device. Affected customers can obtain a copy of the correct IFU by visiting the Maquet website at www.Maquet.com/statlockIFU , by scanning the QR code in the customer letter or by contacting the customer's local Maquet representative. This action has been closed-out on 11/05/2017.

Device

STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) c...
  • Model / Serial
    STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters)Macquet Part Number: 0065-00-0704Products affectedAll lot numbers from 3000001484 to 3000024495ARTG Number: 139645
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA