On April 8, 2017, Medtronic recalled all unused units of the StrataMR adjustable valves and shunts. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.
Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. They control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Medtronic discovered an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid. Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting, and lethargy. If left untreated, under-drainage can potentially lead to coma and death.
As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by the recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015, to November 11, 2016. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata II or Strata NSC products. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.
See the FDA Safety Alert
See the Recall