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FDA ISSUES RECALL NOTICE ABOUT MEDTRONIC DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM

FDA ISSUES RECALL NOTICE ABOUT MEDTRONIC DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM

The FDA recently warned healthcare professionals of a recall of Medtronic Duet External Drainage and Monitoring System. The System is a device used to externally drain and monitor brain fluid. Medtronic Neurosurgery has recalled lots manufactured between March 2013 and February 2014 because of a defect that could cause the line tubing to separate from the line connectors. Such device failure may result in air within the skull, brain infections, or over/under drainage of cerebrospinal fluid. This in turn could lead to grave health issues or death.

Medtronic Neurosurgery has sent Urgent Medical Device Recall letter to its customers, asking them to stop using the affected lots and return all unused devices. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability [of] serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm403876.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm403857.htm

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