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Class I Recall for Medtronic Duet Neuro Drainage System

Class I Recall for Medtronic Duet Neuro Drainage System

July 2, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Duet External Drainage and Monitoring System, a device manufactured by Medtronic that drains cerebrospinal fluid and monitors intracranial pressure.

The problem is that the patient line tubing can disconnect from the patient line connectors, and it is probably more common during frequent handling. According to the recall notification:

“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.”

A spokeswoman for Medtronic told MassDevice that the problem was linked to 35 events from September 2013 through April 2014. No deaths or permanent serious injuries were reported. Medtronic has already addressed the problem and no additional events have been reported.

Recalled products include:

  • Interlink Injection Sites, Catalog Number 46913
  • SmartSite Injection Sites, Catalog Number 46914
  • Interlink Injection Sites, Ventricular, Catheter, Catalog Number 46915
  • SmartSite Injection Sites, Ventricular Catheter, Catalog Number 46916
  • Interlink Injection Sites, Lumbar Catheter, Catalog Number 46917

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