Medical Device Safety and Recalls: Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System - Patient Line Tubing May Disconnect and Lead to Injury

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System - Patient Line Tubing May Disconnect and Lead to Injury

The FDA has issued a recall for the Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System.  The firm recalled the device because the patient line tubing may separate from the patient line connectors. According to the firm, the patient line is more likely to disconnect during frequent handling, such as connections where injections or sampling may frequently occur.  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 firm has not received any reports of deaths.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm403857.htm

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