On April 19. 2017 the U.S. Food and Drug Administration (FDA) announced that Medtronic initiated an urgent recall of its StrataMR adjustable valve and shunt devices. Because of the risk that these medical devices will cause significant adverse health consequences or death, the FDA has identified this as a Class I recall, which is the most serious type of recall.
These valves and shunts are used in the management hydrocephalus, a condition that involves the excessive buildup of cerebrospinal fluid in the brain. The Medtronic StrataMR values and shunts are intended to help regulate the flow of cerebrospinal fluid and prevent excess accumulation. Health care providers use a magnetic tool to adjust the opening pressures of the value to regulate the flow of cerebrospinal fluid. However, the FDA reports that a design problem may cause the valve opening pressures to be higher than specified and therefore increase the resistance to the cerebrospinal fluid flow. This may lead to the under-drainage of fluid, which can then build in the brain cavity and the symptoms of hydrocephalus recur. The FDA states that the use of the affected product may cause serious adverse health consequences, including headaches, nausea, vomiting, coma, and death.
Medtronic has asked customers to discontinue use of the affected products listed on the FDA’s announcement; account for the number of product units implanted or discarded, and return any unused products. Further instructing that if any of the indicated products have been implanted in patients, see the valve adjustments instructions for continued patient care.
If you or a loved one suffered injuries that you believe were caused by Medtronic StrataMR valves and shunts, contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.