The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.

Class I - Dangerous

🏥 Medical Devices Recalled: February 22, 2017 Medtronic Neurosurgery Implants & Prosthetics

What Should You Do?

Check if you have this product:
Worldwide Catalog Number 42955, VALVE 42955 FP-STRATAMR SMALL E03581, E04352, E05120, E05121, E06139, E06476, E09475, E11656, E12556, E12753, E13482, E13483, E13484, E13641, E14518, E14519, E18555, E18556, E18557, E18558, E19670, E19866 Catalog Number 42965, VALVE 42965 FP-STRATAMR REGULAR E03582, E04353, E06015, E06016, E06138, E06412, E09619, E11655, E12041, E12265, E12266, E12950, E12951, E12952, E12953, E13485, E13698, E18559, E18560, E19084, E19540, E19671, E19867, E22208, E22242 Catalog Number 46955, ASSY 46955 FP SHUNT STRATAMR SMALL E12752, E12932, E13573, E16247 Catalog Number 46960, SHUNT 46960 SNAP STRATAMR SMALL E12273, E12780, E12934, E14748 Catalog Number 46965, ASSY 46965 FP SHUNT STRATAMR REGULAR E12779, E12933, E13576, E14270 Catalog Number 46970, SHUNT 46970 SNAP STRATAMR REG E12272, E12620, E12935
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Recall Details

Company:: Medtronic Neurosurgery
Reason for Recall:: Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in CSF fluid performance. This condition may result in the following adverse health consequences: ventriculomegaly, headaches, nausea, vomiting and lethargy. If left untreated, underdrainage has the potential to lead to coma and death.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.

Product Codes/Lot Numbers:

Worldwide Catalog Number 42955, VALVE 42955 FP-STRATAMR SMALL E03581, E04352, E05120, E05121, E06139, E06476, E09475, E11656, E12556, E12753, E13482, E13483, E13484, E13641, E14518, E14519, E18555, E18556, E18557, E18558, E19670, E19866 Catalog Number 42965, VALVE 42965 FP-STRATAMR REGULAR E03582, E04353, E06015, E06016, E06138, E06412, E09619, E11655, E12041, E12265, E12266, E12950, E12951, E12952, E12953, E13485, E13698, E18559, E18560, E19084, E19540, E19671, E19867, E22208, E22242 Catalog Number 46955, ASSY 46955 FP SHUNT STRATAMR SMALL E12752, E12932, E13573, E16247 Catalog Number 46960, SHUNT 46960 SNAP STRATAMR SMALL E12273, E12780, E12934, E14748 Catalog Number 46965, ASSY 46965 FP SHUNT STRATAMR REGULAR E12779, E12933, E13576, E14270 Catalog Number 46970, SHUNT 46970 SNAP STRATAMR REG E12272, E12620, E12935