The StrataMR neurosurgery product falls within the company’s restorative therapies’ brain therapies division.
Here are six things to know:
1. Medtronic decided to issue the voluntary product recall following a boost in the product complaint rate.
2. After making this recall announcement, the company’s shares dropped 0.05 percent.
3. The product complaint rate was 2.75 percent as of April 1, 2017, for all 2,622 distributed StrataMR units.
4. The product is intended to manage hydrocephalus by controlling the cerebrospinal fluid flow drained from the brain to subdue intracranial pressure.
5. Complaints noted following implantation, the product resulted in under-drainage of cerebrospinal fluid. In some cases, this caused headaches, nausea, vomiting and lethargy. And if untreated, this under-drainage could cause coma or death.
6. Medtronic sent a letter requesting customers not use the products still in inventory. The company also alerted the FDA.
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