Medtronic has announced a worldwide recall of an implantable medical device used to relieve fluid pressure from the brain following an increase in complaints about the product, including a patient death that may be related to the problem.
The global device maker, run from executive offices in Minnesota, said on Thursday that doctors should stop using a device called the StrataMR adjustable pressure valve, and return all unused product to the company. The company news release said 2,622 StrataMR valves manufactured between October 2015 and November 2016 were affected by the worldwide voluntary recall.
The StrataMR is an implantable device that gradually relieves intracranial pressure from a condition called hydrocephalus, in which a patient has an abnormal buildup of cerebrospinal fluid in the brain. The device is used to control the flow of fluid from the brain, but an issue with the product can lead to “underdrainage,” the product alert from the company said.
Left untreated, underdrainage of the fluid can lead to coma and death. As of April 1, the product had a complaint rate of 2.75 percent of all units distributed. Although one patient has died, the product alert said the fatality has not been confirmed to be related to the issue.
The StrataMR, which is intended to be safe for use with magnetic-resonance imaging scanners, received sales clearance from the FDA in May.
The recall announced Thursday does not affect the similarly named Strata II or Strata NSC hydrocephalus valves.
However, in February the U.S. Food and Drug Administration announced more than 300,000 units of those devices were the subject of a voluntary field action that updated the device’s instructions after Medtronic received five reports of discrepancies between the valve’s pressure setting and the actual reading determined via X-ray.