Medtronic has notified customers of a voluntary recall of all unused units of the StrataMR adjustable valves and shunts. These products are manufactured and marketed by Medtronic's Neurosurgery business, which is part of the Brain Therapies division of the company's Restorative Therapies Group.
This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata II or Strata NSC products.
As of the initiation of this recall, 2622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016.
Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.