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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00067-1
Product Name/Description	Medtronic Ardian Symplicity Catheter System Model RDN 006 All lot numbers are affected ARTG Number: 198985
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/01/2013
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic has observed a connection issue with the Medtronic Ardian Symplicity Catheter System that can cause unstable temperature readings or lack of signal to the generator. In events where a connection failure leads to unstable temperature reading, the generator's safety algorithm is triggered and energy delivery is terminated, or if there is a lack of signal to the generator, it will not initiate treatment.
Recall Action	Recall
Recall Action Instructions	If the connection issue occurs the user is advised to assure that the catheter connection plug is fully seated into the generator by unplugging and re-inserting or gently wiggling the connector plug. If the connection issue is not resolved replace the catheter and contact Medtronic to organise return of the device.
Contact Information	02 9888 1283 - Medtronic Regulatory Affairs