FDA: Recall of Medtronic’s StrataMR adjustable valves and shunts

Editor's Note

The Food and Drug Administration (FDA) on April 8 announced the recall of all StrataMR adjustable valves and shunts manufactured by Medtronic (Dublin, Ireland).

The recall was issued because of a postimplantation problem that can lead to under-drainage of cerebrospinal fluid, which can lead to headaches, nausea, vomiting, lethargy, coma, and death.

The affected valves and shunts were manufactured from October 27, 2015 to November 11, 2016.

Posted 04/08/2017] AUDIENCE: Neurology, Surgery ISSUE: Medtronic announced that on February 22, 2017 it notified customers of a voluntary recall of 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.