Medtronic Recalls StrataMR Valves and Shunts

Medtronic has recalled all unused units of the StrataMR adjustable valves and shunts due to an increase in product complaints, a rate estimated at 2.75% percent of total units distributed. The recall does not apply to the Strata II or Strata NSC products, according to a recall notice. The 2,600 affected StrataMR valves and shunts were manufactured from 10/27/2015 to 11/11/2016. November 11, 2016.

The devices are used in managing hydrocephalus and they control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Complaints have identified fluid under-drainage as the main concern, which can result in headaches, nausea, vomiting and lethargy. If left untreated, under-drainage can potentially lead to coma and death. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.