Medtronic Recalls Neurosurgery Catheter Tubing, FDA Identifies As Serious Recall

Medtronic Plc’s MDT Neurosurgery unit on Thursday said it 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.

The FDA has identified this as a Class I recall, the most serious type of recall.

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The EDMS is used for temporary drainage of cerebrospinal fluid (CSF) or CSF sampling in people who have:

• Surgery for open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA).
•  Had TAA/TAAA repair surgery and developed symptoms like paraplegia (a form of paralysis that mostly affects the movement of the lower body).

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.

There have been 26 reported injuries. There have been no reports of death.

The system includes a green-striped tube, stopcocks, a drip chamber, a pressure scale, needleless injection/CSF sampling sites, and a removable bag with measurements and an air vent. 

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.

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Price Action: MDT shares are down 0.74% at $84.92 on the last check Thursday.