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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00842-1
Product Name/Description	Temporary Transvenous Pacing Lead System Model 6416 Five (5) Pack Model Numbers: 6416-100, 6416-140, 6416-200 Single Pack Model Numbers: 6416-100S, 6416-140S, 6416-200S Manufactured after 1 May 2014 ARTG Number: 158765
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/06/2016
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic has identified that the Temporary Transvenous Pacing Lead System is not compliant with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patient’s lead to a possible hazardous voltage.
Recall Action	Recall
Recall Action Instructions	Medtronic is advising users to identify and quarantine all unused, affected product and return to Medtronic. For patients who have previously received treatment using a Model 6416 lead affected by this recall no action is necessary. Patients who are currently receiving treatment should continue to be managed with your standard patient management protocol and per the product labelling warnings and precautions section. This action has been closed-out on 21/03/2018.
Contact Information	1800 668 670 - Medtronic