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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00692-1
Product Name/Description	Riata and Riata ST Silicone Endocardial Defibrillation Leads Riata (8Fr): Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Riata ST (7Fr): Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 All these models have been cancelled from the ARTG
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	5/07/2013
Responsible Entity	St Jude Medical Australia Pty Ltd
Reason/Issue	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.
Recall Action	Hazard Alert
Recall Action Instructions	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
Contact Information	02 9936 1213 - St Jude Medical Cardiac Rhythm Management