Medtronic Recalls Duet External Drainage and Monitoring System
Medtronic is recalling its Duet External Drainage and Monitoring System, due to faulty patient line tubing that may separate from the patient line connectors. Customers should stop using the devices immediately and return any unused systems to Medtronic Neurosurgery, the company said.
The Duet EDMS externally drains and monitors cerebrospinal fluid and monitors intracranial pressure. It is intended for use only when trained personnel are present to oversee monitoring and drainage around the clock, the company said.
According to the Class I recall notice posted to the FDA website July 2, the patient line is more likely to disconnect during frequent handling, such as connections where injections or sampling may frequently occur.
Separation may result in air within the skull, infection — such as meningitis, ventriculitis or encephalitis — and over or under drainage of cerebrospinal fluid, any of which could contribute to serious adverse health consequences, including death, the recall notice says. Medtronic has not received any reports of deaths.
The affected products were manufactured from March 15, 2013 through February 28 and distributed from April 10, 2013 through May 19.
Medtronic sent an Urgent Medical Device Recall letter to its customers on June 9, alerting them to stop using the device and verify that all connections on affected products currently in use are secure and leak-free. — Kellen Owings
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