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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00631-1
Product Name/Description Medtronic Duet External Drainage and Monitoring System (Cerebrospinal fluid drainage system)

Model Numbers: 46913 & 46914

Multiple lot numbers affected

ARTG Number: 162723
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/06/2014
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue The patient line tubing in the affected devices may become disconnected from the patient line stopcock. Investigations undertaken by Medtronic determined that this issue was caused by a combination of using tubing that exceeded the recommended shelf life as well as the cleaning process of the tubing during assembly. Disconnection of the patient line is more likely to occur during handling of the system by a healthcare professional.
Recall Action Recall
Recall Action Instructions Medtronic is advising their customers to cease use of the affected product and return any unused units. If any of the potentially affected products are in use it should be verified that the connections are secure and leak free.
Contact Information 02 9857 9234 - Medtronic Regulatory Affairs