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U.S. Department of Health and Human Services

Class 1 Device Recall StrataMR Adjustable Valves & Shunts

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 Class 1 Device Recall StrataMR Adjustable Valves & Shuntssee related information
Date Initiated by FirmFebruary 22, 2017
Date PostedApril 07, 2017
Recall Status1 Terminated 3 on September 19, 2017
Recall NumberZ-1702-2017
Recall Event ID 76595
510(K)NumberK152700 
Product Classification Shunt, central nervous system and components - Product Code JXG
ProductThe 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.
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 
Recalling Firm/
Manufacturer		 Medtronic Neurosurgery
125 Cremona Dr
Goleta CA 93117-3083
For Additional Information ContactBob Shokoohi
805-571-8400
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionThe 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 rs.mnsfca@medtronic.com with "StrataMR Recall" in the subject line.
Quantity in Commerce2622 units (US = 1796, outside US =826)
DistributionProduct 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JXG
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