Medtronic plc issued a worldwide recall of 2,622 StrataMR adjustable valves and shunts used to drain fluid from the brain due to complaints that the devices are not effectively draining. This issue may result in serious health complications or death in patients treated with the device.
The recall involves all unused StrataMR adjustable valves and shunts manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division on the company’s Restorative Therapies Group. Strata II and Strata NSC products are not involved in the recall.
The Strata MR adjustable valves and shunts are used to treat hydrocephalus, fluid build-up in the cavities deep within the brain. The devices control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Medtronic has received reports that the devices, post-implantation, could under-drain cerebrospinal fluid. This may cause the patient to experience headaches, nausea, vomiting and lethargy. If left untreated, under-drainage can potentially lead to coma or death.
Medtronic has received one report of a patient death, but the cause of death has not been confirmed to be related to this issue.
Medtronic is informing its customers of this recall and requesting that they stop using affected devices that remain in inventory. Any adverse events or quality problems related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice