Medtronic PLC has voluntarily recalled all unused units of StrataMR adjustable valves and shunts used to manage hydrocephalus because of a problem that can occur after implantation that can lead to under-drainage of cerebrospinal fluid (CSF), the company said.
Under-drainage of CSF may result in several adverse health consequences, including headaches, nausea, vomiting, and lethargy. If left untreated, under-drainage can lead to coma and death, they note.
"There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue," the company said in a statement posted on the US Food and Drug Administration (FDA) website.
At the start of the recall, 2622 StrataMR valves and shunts that are potentially affected by this recall had been distributed worldwide. The devices are manufactured and marketed by Medtronic's Neurosurgery business, which is part of the Brain Therapies division of the company's Restorative Therapies Group.
The recalled products were manufactured between October 27, 2015, and November 11, 2016. The recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata II or Strata NSC products.
Medtronic said it initiated the recall because of an increase in complaints related to the products. As of April 1, 2017, the product complaint rate related to this issue was 2.75% of total units distributed, they said.
Medtronic is requesting that customers return all unused StrataMR valves and shunts.
In the event that a recalled product has been implanted in a patient, physicians are advised to refer to the StrataMR customer recall letter sent February 22, 2017, as well as the valve adjustment instructions in the instructions for use for continued patient care.
For more information on this recall or to report a problem with the recalled devices, physicians may contact Medtronic via phone at 1.800.335.9557 between 8:00 am and 6:00 pm Eastern Standard Time, or via email at RS.MNSFCA@Medtronic.com.
Healthcare providers are encouraged to report adverse events related to the use of this product to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Cite this: Medtronic Recalls All StrataMR Valves, Shunts for Hydrocephalus - Medscape - Apr 10, 2017.