Medtronic (NYSE:MDT) 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 issue can occur when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance as a result of the MRI resistance key being placed on top of one of the MRI resistance walls instead of one of the pressure setting walls, the company said. The issue can only occur during the valve adjustment process, Medtronic added.
Medtronic said it has received an increase in complaints about the StrataMR, but there have been no reports of death so far.
The company provided appropriate instructions for use for implanted units, and instructed customers with unused valves to contact a local representative to return and replace the devices as necessary.
Medtronic said it has been in contact with regulatory bodies about the issue.