Medtronic has issued a voluntary recall of all unused units of its StrataMR adjustable valves and shunts. The company notified customers on February 22, and the recall could affect 2622 valves and shunts worldwide. The complaint rate of the products related to this issue, which were manufactured between November 11, 2016 and April 1, 2017, was 2.75% of the total units distributed.
Attend the HHE, Benefit-Risk and Recall conference | May 17–18, 2017 | Washington, D.C. or via webcast | Learn moreThe products are part of Medtronic’s neurosurgery business and are used to manage hydrocephalus and relieve intracranial pressure by controlling the flow of cerebrospinal fluid being drained from the brain. The recall relates to a post-implant issue that can lead to under-drainage of cerebrospinal fluid. Adverse consequences include headache, nausea, vomiting and lethargy, and under-drainage can lead to coma and death.
Medtronic has notified customers and has asked that they stop using all affected product and return unused units to the company.
According to the announcement, one patient death has been reported, but there’s been no confirmation that the death is related to the recall issue.