Medtronic StrataMR Recall Issued for Adjustable Shunts and Valves
Federal regulators have announced a recall for Medtronic StrataMR adjustable valves and shunts, warning that the devices may not operate properly, placing patients at risk for serious injury or death.
A Medtronic StrataMR recall was announced on April 6, indicating that the devices may fail to drain enough cerebrospinal fluid, resulting in headaches, nausea and vomiting. If untreated, the problem can lead to coma or other life-threatening complications.
To date, at least one patient death has been associated with the recalled shunts and valves. However, Medtronic indicates that the cause of death has not been conclusively linked to a recalled StrataMR.
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Learn MoreMedtronic StrataMR shunts and valves are used to manage hydrocephalus. They are implanted in the brain to control the flow of cerebrospinal fluid drained from the brain, to relieve intracranial pressure. However, due to a problem with the product, after the valves or shunts are implanted, patient’s can experience under-drainage of fluid. This can cause a flow issue and create higher-than-intended flow resistance.
The recall was announced by Medtronic after the company discovered an increase in the product complaint rate. The company indicated problems impacted 2.75 percent of total units distributed as of April 1, 2017.
Approximately 2,600 StrataMR valves and shunts are affected by the recall, which manufactured from October 27, 2015 to November 11, 2016 and distributed globally. The recall only applies to StrataMR adjustable valves and shunts and does not affect Strata II or Strata NSC products.
The recalled StrataMR shunts and valves are manufactured by Medtronic’s Neurosurgery business, which is a part of the Brain Therapies division of the company’s Restorative Therapies Group.
Medtronic and the FDA advise customers to stop using affected products that remain in inventory and return all unused units to Medtronic. For products already implanted in patients, doctors should refer to the StrataMR customer recall letter sent Feb 22, 2017.
Doctors and patients should monitor a patient’s condition closely. If they experience any side effects or symptoms, they should notify their doctor immediately. Medtronic also noted valve adjustment instructions are included in the instructions for use for patient care.
Any side effects experienced as a result of Medtronic StrataMR valves or shunts should be reported immediately to the FDA MedWatch adverse event reporting program.
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