Class 1 Recall: Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. The device provides continuous cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the health care provider to non-invasively adjust the valve pressure with a magnetic tool.
Reason for Recall
Medtronic is recalling the StrataMR Adjustable Valves and Shunts due to a design problem which may cause the valve opening pressures to be higher than specified and increase the resistance to the cerebrospinal fluid flow. If this occurs, there is the potential for under-drainage of fluid. Underdrainage occurs when the cerebral spinal fluid is not removed quickly, fluid builds up in the brain cavity and the symptoms of hydrocephalus recur. The use of affected product may cause serious adverse health consequences, including headaches, nausea, vomiting, coma, and death.
Who May be Affected
What to Do
On, February 22 2017, Medtronic sent an Urgent Medical Device Recall letter to affected customers. The notice also asked customers to:
Customers with questions related to this recall are instructed to contact Medtronic by phone at 1-800-335-9557 between the hours of 8am and 6pm (EST) or by e-mail at RS.MNSFCA@Medtronic.com.
Date Recall Initiated
February 22, 2017