The FDA notified healthcare professionals particularly associated with neurology/neurosurgery of a Class I recall of the 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 cerebrospinal fluid that may contribute to serious adverse health consequences, including death.
The Medtronic Duet External Drainage and Monitoring System (EDMS) externally drains and monitors cerebrospinal fluid (CSF) and monitors intracranial pressure (ICP). The device is intended to be used only when trained personnel are present to supervise monitoring and drainage 24-hours a day. The affected products were manufactured from March 15, 2013, through February 28, 2014, and distributed from April 10, 2013, through May 19, 2014.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Communication