July 2, 2014 — Medtronic Inc. has issued a Class I recall for the Duet External Drainage and Monitoring System because the patient line tubing can disconnect from the patient line connectors and cause severe, life-threatening injuries.
Medtronic believes the problem is more likely to occur during frequent handling. According to the recall notification from the U.S. Food and Drug Administration (FDA):
“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.”
Although the FDA did not report injuries, a spokeswoman for Medtronic told MassDevice that 35 events were reported between September 2013 and April 2014. There were no permanent serious injuries, no deaths, and no additional reports after Medtronic addressed the issue.
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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