The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospi...
FDA Device Recall #Z-1702-2017 — Class I — February 22, 2017
Recall Summary
| Recall Number | Z-1702-2017 |
| Classification | Class I — Serious risk |
| Date Initiated | February 22, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Neurosurgery |
| Location | Goleta, CA |
| Product Type | Devices |
| Quantity | 2622 units (US = 1796, outside US =826) |
Product 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.
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.
Distribution Pattern
Product was distributed throughout the US and to Australia, Belgium, Canada, Finland, Germany, Hong Kong, Israel, Italy, Japan, New Zealand, Norway, Poland, Portugal, the Russian Federation, Singapore, Spain, Sweden, Switzerland, Turkey, and the UK.
Lot / Code Information
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
Other Recalls from Medtronic Neurosurgery
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0662-2025 | Class I | Exacta External Drainage and Monitoring System:... | Nov 1, 2024 |
| Z-0661-2025 | Class I | Becker External Drainage and Monitoring System:... | Nov 1, 2024 |
| Z-1164-2024 | Class I | Medtronic Duet External Drainage and Monitoring... | Jan 22, 2024 |
| Z-1166-2024 | Class I | Medtronic Duet External Drainage and Monitoring... | Jan 22, 2024 |
| Z-1163-2024 | Class I | Medtronic Duet External Drainage and Monitoring... | Jan 22, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.