Medtronic PLC is recalling all unused units of its StrataMR™ adjustable valves and shunts amid reports of the devices not functioning properly, placing patients at risk for serious injury or death.
Free Confidential Lawsuit Evaluation: If you or a loved one experienced side effects from Medtronic StrataMR valves or shunts, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the problem?
April 24, 2017 – Medtronic issued a global Class I Recall following multiple reports of StrataMR adjustable valves and shunts not draining enough cerebrospinal fluid (CSF) during use, according to an FDA Safety Alert issued April 6. When this occurs, patients implanted with these devices may experience side effects including headaches, nausea and vomiting.
To date, at least one patient death has been associated with StrataMR valves and shunts; however, Medtronic indicates that the fatality has not been conclusively linked to its products.
Medtronic StrataMR shunts and valves are used to manage hydrocephalus (“water on the brain”). They are implanted in the brain to relieve intracranial pressure by controlling the flow of CSF drained from the brain.
However, due to a problem with the devices, patients can experience under-drainage of fluid which can cause a flow issue and create higher-than-intended flow resistance. If left untreated, under-drainage may potentially lead to coma and/or death.
The recall includes approximately 2,622 StrataMR valves and shunts that were manufactured from Oct. 27, 2015 to Nov. 11, 2016. Medtronic has advised physicians to stop using the StrataMR valve and to return all unused devices.
FDA said the complaint rate associated with the Medtronic valves and shunts was 2.75% of the total units distributed as of April 1.
Do I Have a Medtronic StrataMR Recall Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Medtronic StrataMR lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you were injured by Medtronic StrataMR valves or shunts, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.