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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 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