Medtronic is recalling its Duet External Drainage and Monitoring System, a device that externally drains and monitors cerebrospinal fluid (CSF) and monitors intracranial pressure (ICP), because the patient tubing line may separate from the patient line connectors. This is more likely to occur during frequent handling, such as when injections or sampling is needed.
This defect could cause air in the skull, a condition known as pneumocephalus; infections such as meningitis, ventriculitis, or encephalitis; and over or under drainage of the cerebrospinal fluid that could lead to serious adverse health consequences, including death. To date, there have been no reports of fatalities.
The Medtronic Duet External Drainage and Monitoring System is intended to be used only when trained personnel are present to supervise monitoring and drainage 24 hours a day.
The recall is a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Medtronic sent its customers an Urgent Medical Device Notice notifying which actions should be taken with the device. Any adverse events or quality problems associated with this device should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.