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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00297-1
Product Name/Description	Medtronic StrataMR Adjustable Valves & Shunts used in the management of hydrocephalus StrataMR Valve, Small Catalogue Number: 42955 Serial Numbers: E06139, E06476, E09475, E12753, E13484, E13641, E18556, E18557, E18558 StrataMR Valve, Regular Catalogue Number: 42965 Serial Numbers: E06016, E06138, E06412, E09619,E12266, E12952, E18559, E18560 Strata MR Shunt Assembly, Small Catalogue Number: 46955 Serial Number: E12932 ARTG Numbers: 129681, 134740
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	2/03/2017
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Specific StrataMR Adjustable Valves & Shunts may experience a condition which may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (CSF). The condition can occur when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance. This higher than intended flow resistance is a result of the MRI Resistance Key on the bottom of the valve’s rotor mechanism being placed on top of one of the MRI Resistance Walls, instead of in one of the pressure setting wells. The incorrect valve rotor orientation can be caused by misalignment and/or off-center positioning of the StrataMR Locator Tool, relative to the valve mechanism during the valve adjustment process. This condition may result in headaches, nausea, vomiting and lethargy. If left untreated underdrainage has the potential to lead to coma and death. To date, there have been no reports of death.
Recall Action	Recall
Recall Action Instructions	Customers are advised to discard and return any unused units to Medtronic. For products that have been implanted in patients, clinicians are reminded that for continued patient care that it is critical to properly align and center the Locator Tool over the valve mechanism to ensure that the valve is set at the desired pressure. Instructions that will aid in proper technique are included in the Instructions for Use and reiterated in the customer letter. This action has been closed out on 26/02/2019
Contact Information	02 9857 9289 - Medtronic Product Specialist Neurosurgery