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Class I Recall: StrataMR Adjustable Valves and Shunts

Posted on 04/24/2017Back

 An Overview of the Recall

  • Who: Medtronic and the FDA
  • What: StrataMR adjustable valves and shunts
  • When: from February 22, 2017 to present
  • Where: worldwide
  • Why: StrataMR adjustable valves and shunts can malfunction causing headaches, nausea, vomiting, lethargy, coma, and death

What is a StrataMR adjustable valve and shunt?

A valve and pump that’s implanted in the brain. It’s used to treat hydrocephalus, a medical condition where too much fluid builds up inside the brain. If left untreated (or improperly treated), hydrocephalus can cause headaches, nausea, vomiting, lethargy, coma, and death.

How does a StrataMR adjustable valve and shunt work?

A properly functioning StrataMR adjustable valve and shunt treats hydrocephalus by regulating the amount, flow direction, and pressure of brain fluid.

What’s wrong with StrataMR adjustable valves and shunts?

Some of them aren’t draining brain fluid fast enough. The result is that for some patients, excess brain fluid is building up. Again, an excessive buildup of brain fluid can cause headaches, nausea, vomiting, lethargy, coma, and death. One death has been reported so far, but it hasn’t yet been proven whether the patient’s StrataMR adjustable valve and shunt caused their death.

What’s being done about this?

Medtronic voluntarily recalled all unused StrataMR adjustable valves and shunts on February 22, 2017. This means that surgeons who had StrataMR adjustable valves and shunts to implant are sending them back to Medtronic. The FDA classified this as a “Class I Recall” on April 20, 2017. Recalls are classified according to the danger the recalled device poses to the public. A Class I recall is the most serious type; the FDA only uses this classification when a device can cause death.

What should you do if you or a loved one has a StrataMR adjustable valve and shunt implant?

First, contact the surgeon who implanted your StrataMR adjustable valve and shunt. They’ll be able to tell you if your StrataMR valve and shunt has been recalled (neither Strata IIs nor Strata NSCs are included in this recall). They’ll also be able to tell you if your Strata MR valve and shunt is malfunctioning. They should also be able to tell you what to do next if your Strata MR valve and shunt is malfunctioning. If you think there’s a chance you or your loved one might have this device implanted, please see your surgeon immediately to make sure everything is functioning properly.

Category News Personal Injury