Recall of Duet External Drainage and Monitoring System
Medtronic is recalling its Duet External Drainage and Monitoring System due to faulty patient line tubing that may separate from the patient line connectors. The Duet EDMS externally drains and monitors cerebrospinal fluid and monitors intracranial pressure.
According to the FDA’s Safety Alert, the device failure may result in air within the skull (pneumocephalus), infection (such as meningitis, ventriculitis, encephalitis) and over/under drainage of the CSF that may contribute to serious adverse health consequences, including death.
The affected products were manufactured from March 15, 2013 through February 28, 2014 and distributed from April 10, 2013 through May 19, 2014. See the recall notice for a listing of the affected lot numbers.
Our defective medical drug and device attorneys at the law firm of Zoll & Kranz, LLC represent victims and families of victims injured or killed because of recalled medical drugs or devices. For more information about the recall of Medtronic’s Duet system, call toll-free (888)841-9623.
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