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Medtronic voluntarily recalls StrataMR adjustable neurological valves, shunts

Medtronic PLC voluntarily recalled all unused units of its StrataMR adjustable valves and shunts, used to manage hydrocephalus, on Feb. 22.

The company recalled the products due to the heightened product complaint rate related to a post-implantation issue that could lead to under-drainage of cerebrospinal fluid. If left untreated, under-drainage of the fluid may result in coma and death.

As of April 1, the product complaint rate reached 2.75% of total units distributed. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.

The recall only affects StrataMR valves and shunts manufactured from Oct. 27, 2015, to Nov. 11, 2016, and does not apply to Strata II or Strata NSC products.

According to Medtronics, about 2,622 of the affected products were distributed worldwide.