Medtronic has announced a voluntary recall of 2,622 StrataMR valves and shunts due to an increase in complaints. The valves and shunts, used in hydrocephalus management, control the flow of cerebrospinal fluid that is drained from the brain and is used to help relieve intracranial pressure. Unfortunately, complaints indicate the valves and shunts may lead to under-drainage of cerebrospinal fluid, which could result in nausea, vomiting, lethargy and headaches. If left untreated, under-drainage may ultimately lead to coma or even death.
The valves and shunts were manufactured and marketed by Medtronic’s Neurosurgery division, and they were distributed worldwide. The recall affects products manufactured between October 27, 2015 and November 11, 2016. There has been one report of death, although it has not yet been confirmed if it is related to this potentially defective product.
Medtronic has issued a notice to customers and has requested physicians to immediately cease use of the product.
As consumers, we expect the medical devices and products such as this to be safe and effective. The Ruth Law Team’s experienced product liability attorneys hold manufacturers accountable for dangerous products placed on the market that have caused injury to innocent consumers. If you feel you were physically injured due to an unsafe medical product or device, call 888-783-8378 for a free consultation with one of our personal injury lawyers who will help determine the best course of action.