It is important to note that the medtronic delta fixedpressure valve and csfflow control valves are not included in this recall. Apr 10, 2017 federal regulators have announced a recall for medtronic stratamr adjustable valves and shunts, warning that the devices may not operate properly, placing patients at risk for serious injury or death. Class 2 device recall strata ii strata nsc valves fda. Food and drug administration fda announced that medtronic initiated an urgent recall of its stratamr adjustable valve and shunt devices. An informative exchange and support forum for people with hydrocephalus, their families, and new parents helping to answer the questions. Fda has advised physicians to stop using affected products, and to return all unused lots to medtronic.
Medtronic recalls stratamr valves for brain fluid drainage. Medtronic issues a recall for its stratamr valves, shunts. The fda and medtronic neurosurgery brain therapies issued a class i recall for all unused stratamr adjustable valves and shunts that drain fluid from the skull. Medtronic neurosurgery brain therapies initiated a voluntary recall for all unused lots of the stratamr valve and shunt systems on february 22, 2017 in a field safety notice pdf to surgeons. Medtronic has announced a voluntary recall of 2,622 stratamr valves and shunts due to an increase in complaints. Medtronic is also undertaking a recall of devices that have not yet been implanted. Pre and post operative adjustment of strata valves youtube. Medtronic stratamr valve class action lawsuit medtronic. They control the flow of cerebrospinal fluid being drained from the brain to relieve pressure. The recall does not affect strata ii or strata nsc products. Apr 10, 2017 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. Medtronic announces voluntary worldwide recall of its. If you were injured by a defective medtronic strata mr valve, contact our lawyers for lawsuit info at 866 9200753.
Apr 06, 2017 medtronic initiated the recall due to an increase in the product complaint rate. Dublin april 6, 2017 medtronic plc today announced that on february 22, 2017 it notified customers of a voluntary recall of all unused units of the stratamrtm adjustable valves. Medtronic voluntarily recalls stratamr adjustable valves and. Medtronic stratamr valves and shunts therapeutic goods. This recall only applies to stratamr adjustable valves and shunts and does not apply to strata ii or strata nsc products. Demonstration of preoperative and postoperative adjustment of the strata valve using the strata. May 16, 2016 medtronic stratamr valve lawsuit if you or a loved one received a medtronic stratamr adjustable valve and shunt and suffered serious complications associated with the underdrainage of brain fluid, contact attorney group for more information about your options. Mdt this month initiated a voluntary recall of all unused stratamr adjustable valves and shunts over issues with the flow resistance in the valve which may result in under drainage of cerebrospinal fluid. Medtronic issues voluntary global recall for stratamr. Noninvasive pressure setting adjustment may reduce the need for revision. Strata valve products contain a magnet inside the valve mechanism that allows the neurosurgeon to change the pressure setting of the valve in his office. Apr 17, 2017 medtronic issues global stratamr valve and shunt recall, instructions to physicians according to the u. Apr 11, 2017 medtronic has issued a voluntary recall of all unused units of its stratamr adjustable valves and shunts.
Food and drug administration fda medtronic plc just announced that, on february 22, 2017, it advised customers of its voluntary recall of all unused units of the stratamr adjustable valves and shunts. Federal regulators have announced a recall for medtronic stratamr adjustable valves and shunts, warning that the devices may not operate properly, placing patients at risk for serious injury or. Medtronic is conducting this voluntary recall due to an issue that can occur postimplantation that can lead to the potential for underdrainage of cerebrospinal fluid. April 11, 2017 the fda announced a voluntary recall for all medtronic stratamr shunt valve systems because they may fail to drain cerebrospinal fluid, resulting in coma or death. Medtronic recalls strata mr valves that drain brain fluid.
Medtronic recalls stratamr valves and shunts medtronic has announced a voluntary recall of 2,622 stratamr valves and shunts due to an increase in complaints. Medtronic strata ii strata nsc valves therapeutic goods. Medtronic recalls all stratamr valves, shunts for hydrocephalus. Medtronic stratamr valve lawsuit lawyer recalls, claims. Medical device maker, medtronic, just implemented a voluntary recall of all unused stratamr adjustable valves and shunts due to problems with the valves flow resistance, which may cause underdrainage of cerebrospinal fluid. Medtronic stratamr adjustable valves and shunts are used in the management of hydrocephalus. Medtronic confirms stratamr valve and shunt recall massdevice.
Medtronic issues global recall of stratamr valves and shunts. Medtronic stratamr recall issued for adjustable shunts and. Medtronic said it initiated the recall because of an increase in complaints. Medtronic addresses fda recall for strata iistrata nsc and. Medtronic is recalling the stratamr adjustable valves and shunts due to a design problem which may cause the valve opening pressures to be. Today medtronic said it began notifying customers feb. Medtronic issued a field safety notice pdf to surgeons on february 22, 2017 after receiving at least 72 complaints 2. Mar 27, 2017 medtronic stratamr adjustable valves and shunts recalled over flow resistance issues. Strata valves and magnetic fields the medtronic strata products are a valve technology used in the treatment of hydrocephalus. Mdt this month initiated a voluntary recall of all unused stratamr adjustable valves and shunts over issues with the flow resistance in the valve which may result in under. Medtronic recalls stratamr adjustable valves and shunts.
Medtronic is conducting a voluntary recall of the stratamr valve due to an issue that can occur postimplantation that can lead to the potential for underdrainage of cerebrospinal fluid. Medtronic is also undertaking a recall for product correction to update the instructions for use ifu to take account of this issue. Medtronic neurosurgery has announced a voluntary recall of all unused units of the stratamr adjustable valves and shunts, which are used to. The strata iistrata nsc valves were first made available in the u. Medtronic has announced that on 22 february, 2017 it notified customers of a voluntary recall of all unused units of the stratamr adjustable valves and shunts. Strata adjustable pressure valves are part of a shunt system used to treat the symptoms of hydrocephalus. Mdt yesterday confirmed the recall of its stratamr adjustable valves and shunts, reported last month. The strata adjustable pressure valves are used to treat hydrocephalus, or water on the brain, a birth defect in which excess cerebrospinal. The recall covers 2,622 stratamr units made between oct. Apr 11, 2017 medtronic neurosurgery brain therapies recalled all unused strata mr valves that drain excess fluid in the skull due to a flowresistance problem that could cause underdrainage of cerebrospinal fluid.
The valves and shunts, used in hydrocephalus management, control the flow of cerebrospinal fluid that is drained from the brain and is used to help relieve intracranial pressure. The recall announced thursday does not affect the similarly named strata ii or strata nsc hydrocephalus valves. If you were implanted with a medtronic shunt or valve, you should contact your doctor immediately if you experience any of the above symptoms. Oct 27, 2015 medtronic is recalling the stratamr adjustable valves and shunts due to a design problem which may cause the valve opening pressures to be higher than specified and increase the resistance to the. Medtronic has proactively implemented a field corrective action fca for its strata iistrata nsc valves. Apr 07, 2017 today medtronic said it began notifying customers feb. Medtronic is recalling the stratamr adjustable valves and shunts due to a design problem which may cause the valve opening pressures to be higher than specified and increase the. The company notified customers on february 22, and the recall could affect 2622 valves and shunts worldwide. Medtronic neurosurgery is recalling the csfunitized shunts, delta shunt assembly kit, and the strata ii shunt assembly kit because they were found to have label discrepancies.
The form and function of medtronic strata ii shunt valves. Mdt today announced that on february 22, 2017 it notified customers of a voluntary recall of all unused units of the stratamr adjustable valves and shunts. Medtronic neurosurgery sent an urgent medical device recall letter dated november 18, 20, to all affected customers. There is also a valve called a strata nsc no siphon control but we dont really use this, unless its a lumboperitoneal shunt. Medtronic recalls stratamr adjustable valves and shunts which. This type of fca is referred to by the fda as a class.
Medtronic announces voluntary worldwide recall of its stratamr. This video discusses the design of the medtronic strata valve, with adjustable pressure capabilities, and the csf pathway through the valve, from the ventricular or proximal catheter to the. These products are manufactured and marketed by medtronics neurosurgery business, which is part of the brain therapies division of the. Medtronic strata ii strata nsc valves includes burr hole and lumbar peritoneal. Medtronic initiated the recall due to an increase in the product complaint rate. The recall only applies to stratamr adjustable valves and shunts and does not apply to strata ii or strata nsc products. Feb 02, 2016 this video discusses the design of the medtronic strata valve, with adjustable pressure capabilities, and the csf pathway through the valve, from the ventricular or proximal catheter to the. Programmable differential pressure valve with integrated gravity activated component point of confusion. Apr 07, 2017 dublin april 6, 2017 medtronic plc nyse. Class 2 device recall medtronic strata ii shunt assembly kit. Medtronic confirms stratamr valve and shunt recall. Changing the pressure setting of the valve does not require. Medtronic strata iistrata nsc valves are used in the management of hydrocephalus.
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