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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 valveā€™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