Medical Device Safety and Recalls: Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain

Medtronic is recalling the StrataMR Adjustable Valves and Shunts due to a design problem which may cause the valve opening pressures to be higher than specified and increase the resistance to the cerebrospinal fluid flow. If this occurs, there is the potential for under-drainage of fluid. Underdrainage occurs when the cerebral spinal fluid is not removed quickly, fluid builds up in the brain cavity and the symptoms of hydrocephalus recur. The use of affected product may cause serious adverse health consequences, including headaches, nausea, vomiting, coma, and death.

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