Medtronic Recalls Unused StrataMR Valves and Shunts
Medtronic this month initiated a voluntary recall of all unused StrataMR adjustable valves and shunts over issues with the flow resistance in the valve which may result in under drainage of cerebrospinal fluid.
The Fridley, Minn.-based company said such a condition can occur in the units when the valve mechanism is adjusted to a position which causes higher than intended flow resistance.
Such an issue can lead to adverse health consequences including headaches, nausea, vomiting and lethargy, and if not corrected, eventually coma or death, Medtronic said in its recall notice.
The Fridley, Minn.-based company said such a condition can occur in the units when the valve mechanism is adjusted to a position which causes higher than intended flow resistance.
Such an issue can lead to adverse health consequences including headaches, nausea, vomiting and lethargy, and if not corrected, eventually coma or death, Medtronic said in its recall notice.