Events

Recall of Lotus Valve System (transcatheter aortic valve implantation (TAVI) system)

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-01016-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01016-1
  • 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 is undertaking a recall of the lotus valve system to remove units from the field that were manufactured prior to a component related change made in march 2016. this action is related to release mandrel breaks. the release mandrel is a component of the delivery system that is connected to the release pin which facilitates release of the valve from the delivery system.Products manufactured after the implementation of the component change are not impacted. boston scientific has not received any reports of release mandrel breaks for units built after this change. there is no impact to previously implanted devices since the issue only involves the delivery system and is not related to the performance of the implanted valve.
  • Action
    Boston Scientific is advising users to immediately discontinue use of and segregate affected product. Boston Scientific will arrange for the return of affected product. This action has been closedd-out on 16/02/2017.

Device

Lotus Valve System (transcatheter aortic valve implantation (TAVI) system)
  • Model / Serial
    Lotus Valve System (transcatheter aortic valve implantation (TAVI) system) Product numbers : H749LTV230, H749LTV250, H749LTV270Affected lot numbers remaining in the market : 18948721, 18948723, 18948521ARTG Number: 260448
  • 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