The Medtronic Duet External Drainage and Monitoring System is now the subject of a Class I recall, the FDA’s highest classification and reserved for situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or 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.
Medtronic issued a recall notice in early June because of concerns that 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.
While there have not been any reports of death, it is possible that device failure may result in pneumocephalus, infection (such as meningitis, ventriculitis, encephalitis) and over/under drainage of the CSF that carry that risk.
The affected products were manufactured from March 15, 2013 through February 28, 2014 and distributed from April 10, 2013 through May 19, 2014 and full details of lot numbers can be found on the FDA recall notice here.
Customers are instructed to stop using the affected product and return all unused devices to Medtronic Neurosurgery, completing and return the Customer Product Accountability Form enclosed with the recall letter.
If affected products are in use, customers should verify all connections are secure and leak-free per the Instructions for Use.