Medtronic Catheter Tubing Potential Disconnection Deemed Class I Recall

Medtronic Neurosurgery’s recall of its Duet External Drainage and Monitoring System (EDMS) catheter tubing due to a potential for the catheter disconnection from the patient line stopcock connectors has been identified as a Class I recall by the FDA.

Five models of the Duet EDMS are involved in the recall of 45,176 units, according to the FDA. 

If the tubing becomes disconnected, there is a potential harm for infection, cerebrospinal fluid leakage and over drainage of cerebrospinal fluid, which could lead to neurological injury or death if the disconnection is undetected. There have been 26 reported injuries and no reports of death, the FDA said, among the 45,176 devices distributed between May 3, 2021, and Jan. 9.

Read the FDA announcement for the Medtronic recall here.

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