Events

Recall of Imager II Angiographic Catheter

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-2016-RN-01654-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01654-1
  • 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
    Boston scientific has received a field report noting that some units within a certain lot were missing the bottom pouch seal that forms part of the sterile barrier. this was caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. although boston scientific has confirmed that only one batch (00112758) was missing a bottom seal, as a precautionary measure, they are notifying all customers of this issue that received batches processed through this alternate label reprint process. on affected product, the compromised seal is completely missing and is obvious to the user. the device can be readily exchanged resulting in an insignificant prolongation in the medical procedure. to date there have been no reports of patient injury associated with a missing pouch seal.
  • Action
    Boston Scientific is advising customers to post the customer letter that details the issue in a visible location near the product to ensure all users are aware of the issue. Users are to immediately discontinue use of and segregate any inventory missing a bottom pouch seal, and then return it to Boston Scientific. Credit will be issued for returned stock. This action has been closed-out on 27/06/2017.

Device

Imager II Angiographic Catheter
  • Model / Serial
    Imager II Angiographic Catheter Various Material Numbers (UPNs) and Batch NumbersExpiry date range: 1 April 2018 - 31 July 2018ARTG Number: 137897
  • Manufacturer
    Boston Scientific Pty Ltd

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