by
Gus Iversen, Editor in Chief | April 10, 2017
StrataMR valves
Courtesy of Medtronic
Medtronic Neurosurgery has announced a voluntary recall of all unused units of the StrataMR adjustable valves and shunts, which are used to control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure in the management of hydrocephalus.
The device got sales clearance in May, 2016, from the FDA and is “intended to be safe for use with magnetic resonance imaging scanners,”
according to the Star Tribune.
There has been one patient death “that may be related to the problem,” according to the Tribune.
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In its March “Urgent Field Safety Notice” to customers, the company stated, “the products identified above may experience a condition that may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (CSF).”
The Model numbers involved are: 42955, 42965, 45905, 46955, 46960, 46965, and 46970.
The communication went on to explain that this can happen “when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance. This higher-than-intended flow resistance is a result of the MR Resistance Key on the bottom of the valve’s rotor mechanism being placed on top of one of the MR Resistance Walls, instead of in one of the pressure setting wells. This condition only occurs during the valve adjustment process.”
A total of 2,622 StrataMR valves and shunts are potentially affected by this recall worldwide,” the company noted in a statement.
All the devices were produced from October 27, 2015 to November 11, 2016.
In cases in which an affected product has been implanted, caregivers 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,” advised the company.
In early 2017, Medtronic was in the news over the closing of its
Covidien purchase, first announced in 2014.
The cash-and-stock transaction was
valued at approximately $49.9 billion.
There was some speculation that it was considering unloading its medical supply business, which it inherited from Covidien, that markets a wide variety of supplies including needles, catheters, monitoring equipment and medical instruments.
