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.
FDA Recall Z-1702-2017 · Posted 2017-04-07
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Recalling FirmMedtronic Neurosurgery
Recall StatusTerminated
Product CodeJXG
Date Initiated2017-02-22
Date Terminated2017-09-19
Product Quantity2622 units (US = 1796, outside US =826)
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.
Firm Action
The firm has initiated a CAPA and issued notification via letter to US Customers on February 22, 2017. As of the date of the report (2/22/17) the firm was still in process of notifying foreign customers. Recipients are instructed to:
1) Cease use of the listed product,
2) Account for number of product units implanted or discarded and return any unused units by completing an attached individualized customer product accountability form provided in the letter,
3) If any of the indicated products have been implanted in patients, to adjust the valves according to instructions listed in an included attachment.
Recipients are asked to fax a customer acknowledgment response form or scan/take a picture of the form and email to [email protected] with "StrataMR Recall" in the subject line.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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