The Medtronic StrataMR adjustable valves and shunts are recall
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain…
Why was The Medtronic StrataMR adjustable valves and shunts are recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain…
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 2622 units (US = 1796, outside US =826)
- Distribution
- 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.
- Recall date
- April 19, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)