The StrataMR adjustable valves and shunts are intended for the management of hydrocephalus by providing cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity.
The recall relates to issues with 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 the FDA. Potential health consequences from the flow issue include headache, nausea, vomiting and lethargy and coma or death if the problem is not addressed.
The FDA identified a total of 1,796 devices affected by the recall, with 6 different model numbers were identified in the recall notice, with 62 different lot numbers, manufactured between Oct. 27, 2015 and Nov. 11, 2016 and distributed between Jan. 7, 2016 and Feb. 21, 2017.
Medtronic said it began notifying customers Feb. 22, noting that the recall does not affect its Strata II or Strata NSC devices.
The company provided instructions for implanted units, instructing customers with unused valves to contact a local representative to return and replace them as necessary.