Medtronic (NYSE:MDT) yesterday confirmed the recall of its StrataMR adjustable valves and shunts, reported last month by MassDevice.com, saying 1 death has been reported but not confirmed to be associated with the issue.
The problem relates to flow resistance that could lead to under-drainage of cerebrospinal fluid, arising when the valve mechanism is adjusted to a position which causes higher-than-intended flow resistance, according to a letter dated March 2017 that the Fridley, Minn.-based company sent to physicians in Europe. Potential health consequences from the flow issue include headache, nausea, vomiting and lethargy and coma or death if the problem is not addressed.
Today Medtronic said it began notifying customers Feb. 22, noting that the recall does not affect its Strata II or Strata NSC devices. The recall covers 2,622 StrataMR units made between Oct. 27, 2015, and Nov. 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% of total units distributed,” the company said. “There has been 1 reported patient death, but the cause of death has not been confirmed to be related to this issue.”
The company provided instructions for implanted units, instructing customers with unused valves to contact a local representative to return and replace them as necessary.