Medtronic Neurosurgery is recalling the Duet External Drainage and Monitoring System (EDMS) catheter tubing due to a potential for the catheter disconnection from the patient line stopcock connectors.
If a tubing disconnection occurs, potential harm to patients may include infections, cerebrospinal fluid leakage, over drainage of cerebrospinal fluid, and abnormality of the ventricles. Uncontrolled over drainage of cerebral spinal fluid could lead to neurological injury or death if the disconnection is undetected.
The Medtronic Duet EDMS is used for temporary drainage of cerebrospinal fluid (CSF) or CSF sampling. This system works by gravity, flowing CSF from an external lumbar catheter through the patient tube, into the drip chamber, and finally into the bag. It’s suggested to use it with the Clear-Site Laser Level provided separately.
The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, indicating it as the most serious type of recall due to the potential for severe injuries or fatalities. There have been 26 reported injuries. There have been no reports of death.
On January 23, 2024, Medtronic sent all affected customers an Urgent Medical Device Recall. In a letter, the company asked customers to Identify and quarantine any unused impacted products. Check all components for damage and that all connections are secure and leak-free and dispose of any impacted product.
