Events

Recall of Riata and Riata ST Silicone Endocardial Defibrillation Leads

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by St Jude Medical 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-2013-RN-00692-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00692-1
  • 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
    This is an update to the 'hazard alert' letter in may 2012 and subsequent update in july 2012 (tga ref.: rc-2012-rn-00391-3) and highlights the following topics: (1) key studies and patient management considerations for patients with riata and riata st silicone leads; (2) the most recent riata lead evaluation study results; and (3) the 2013 1st edition product performance report (ppr).The may 2012 'hazard alert' identified that externalised conductors can occur in riata and riata st silicone leads when an abrasion results in an outer insulation breach within the vascular or cardiac systems allowing the normally contained conductors to become visible outside the lead body. externalised conductors can be a result of relative motion of the conductor cables within the lead insulation lumen, referred to as inside-out abrasion, or from external sources of abrasion, e.G. lead-to-lead abrasion, where the outer insulation is breached.
  • Action
    St Jude Medical is providing updated clinical information to treating clinicians based on the interim results from the ongoing studies on the performance of the Riata and Riata ST leads in long term clinical use related to insulation wear and lead conductor externalisation. Detailed data has been provided by the manufacturer at www.riatacommunication.com

Device

Riata and Riata ST Silicone Endocardial Defibrillation Leads
  • Model / Serial
    Riata and Riata ST Silicone Endocardial Defibrillation LeadsRiata (8Fr): Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592Riata ST (7Fr): Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042All these models have been cancelled from the ARTG
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA