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Medtronic Issues Voluntary Recall of StrataMR Valve

Apr 11, 2017
Medtronic Issues Voluntary Recall of StrataMR Valve

Medtronic has announced a worldwide recall of an implantable medical device called the StrataMR. The device is used to relieve fluid pressure from the brain by gradually relieving intracranial pressure from a condition called hydrocephalus. This is a condition when a patient has an abnormal buildup of cerebrospinal fluid in the brain. The device is a valve used to control the flow of fluid from the brain, but complaints, including a patient death, has prompted the voluntary recall, the Star Tribune reports.

Affected StrataMR Valves or Shunts

The global company with executive offices in Minnesota said that 2,622 StrataMR valves manufactured between October 27, 2015 and November 11, 2016 were affected by the worldwide recall. Medtronic said that doctors should stop using the StrataMR adjustable pressure valve and return all unused product to the company.

The issue with the product may lead to "underdrainage," said the product alert from the company. Under-drainage of cerebrospinal fluid may result in health consequences such as headaches, nausea, vomiting, and lethargy.

Importance of Cerebrospinal Fluid

Cerebrospinal fluid is a clear, colorless fluid that circulates throughout the central nervous system, where it performs a dual role. One benefit, is that the layer of fluid surrounding the brain is able to absorb shock and provide extra padding that helps protect the easily damaged tissues of the central nervous system.

Another important benefit of cerebrospinal fluid is its role in maintaining a healthy circulation through the brain and spinal cord. Cerebrospinal fluid delivers nutrients to these areas and extracts waste in much the same way that blood does for other parts of the body. The free circulation of cerebrospinal fluid, is therefore, essential to keeping individual nerve cells healthy and removing toxic byproducts of normal cell metabolism.

If any of the affected products have been implanted in patients, physicians should refer to the StrataMR customer recall letter sent February 22, 2017, as well as the valve adjustment instructions in the instructions for use (IFU) for continued patient care, the FDA reports.

Underdrainage of the fluid, if left untreated, can lead to coma and death. As of April 1, the medical product had a complaint rate of 2.75 percent of all units distributed. Although, one patient has died, the fatality has not yet been confirmed to be related to the medical device's issue, according to the Star Tribune.

National law firm Parker Waichman LLP has extensive experience and success in medical device litigation. The firm's attorneys are available to answer legal questions from individuals seeking information for a potential lawsuit.

The StrataMR is designed to be safe for use with magnetic-resonance imaging (MRI) scanners. It was approved by the U.S. Food and Drug Administration (FDA) in May 2016. The recent recall does not affect the similarly named Strata II or Strata NSC hydrocephalus valves.

In February, the FDA announced more than 300,000 units of those devices were the subject of a voluntary field action that updated the device's instructions subsequent to Medtronic receiving five reports of discrepancies between the valve's pressure setting and the actual reading determined via X-ray.

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, according to the FDA. Medtronic is headquartered in Dublin, Ireland and is among the world's largest medical technology, services and solutions companies.

Previous Medtronic Valve Issues

Previous Medtronic Valve Issues

In August 2016, a warning was issued concerning the EnVeo R delivery system used to implant the Evolut R aortic valve in the heart. Medtronic PLC alerted doctors of complication from aortic stenosis. Medtronic issued the warning due to 19 patients who died of severe blood vessel trauma. The device is used to treat patients with a narrowing of the arteries (aortic stenosis).

Complications from aortic stenosis include heart failure, irregular heart rhythm and fainting. The notice last year indicated 7,300 EnVeo R delivery systems in the United States and 24,000 worldwide were implicated. Medtronic identified 39 patients who suffered damage to the arteries when the EnVeo R was used; 19 of those patients died. Although the number of cases is low compared to the tens of thousands that were implanted, the complications are often fatal.

Advice and Information for Medical Device Problems

If you or someone you know suffered injuries regarding the use of a Medtronic StrataMR valve or shunt, you may have valuable legal rights. The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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