Medtronic has pulled all unused units of the StrataMR valves and shunts from the market after logging an increase in product complaints, including one reported patient death.

Qmed Staff Report

Dublin-based Medtronic plc said this week that an increase in product complaints prompted a Feb. 22 recall of all unused units of the StrataMR adjustable valves and shunts.

Roughly 2,622 of the affected devices had been distributed worldwide, and the company said the product's complaint rate as of April 1 was 2.75%. FDA cleared the products for marketing last year.

The company's neurosurgery business made the affected StrataMR valves and shunts from Oct. 27, 2015 to Nov. 11, 2016. The devices are used in the management of hydrocephalus, and are designed to control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure.

The product complaints relate to an under-drainage problem that can cause headaches, nausea, vomiting, and lethargy. Left untreated, the problem can be deadly. One patient has already died, Medtronic said, but it is not yet known if under-drainage was the cause of death.

[Image credit: Medtronic plc]