Medtronic PLC has issued a Class I Recall for its StrataMR™ adjustable valves and shunts after the devices were found not to work properly, which could increase the risk of serious injury or death in patients who received the products.
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 lawsuit and our lawyers can help.
What’s the Problem?
According to an FDA Safety Alert issued on April 6, 2017, Medtronic StrataMR™ adjustable valves and shunts may fail to drain enough cerebrospinal fluid (CSF), which may cause patients to suffer headaches, nausea and vomiting.
One patient death has potentially been related to defective StrataMR valves and shunts; however, this has not yet been confirmed, according to Medtronic.
The valves and shunts are designed to manage the accumulation of CSF, which helps to relieve intracranial pressure. However, a problem with the devices may lead to under-drainage following implantation, FDA warns.
About 2,600 StrataMR valves and shunts are affected by the recall, which were manufactured between Oct. 27, 2015 and Nov. 11, 2016. The recall does not affect Strata II or Strata NSC products.
FDA has advised physicians to stop using affected products, and to return all unused lots to Medtronic.
If you were implanted with a Medtronic shunt or valve, you should contact your doctor immediately if you experience any of the above symptoms.
Do I Have a Medtronic StrataMR Valve Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Medtronic StrataMR Valve 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 lawsuit and we can help.