Medtronic Duet

2024: Product Recall

On March 7, 2024 U.S. Food and Drug Administration (FDA) , it announced the recall of the defective catheter tubes of Medtronic the Duet external drainage and monitoring system. The use of these products in severe cases can provoke the death of the patient.

Medtronic Duet is an external cerebrospinal fluid (CSF) drainage system that is designed for both ventricular and lumbar drainage. The complex can be used to reduce intracranial pressure, for example, in the postoperative period, to monitor the chemical composition, cytology and physiology of CSF, as well as to provide temporary CSF drainage for patients with infected cerebrospinal fluid shunts.

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The FDA notice says defective products have the potential to disconnect the catheter from the patient's line shut-off valve connectors. This can lead to infections, leakage of cerebrospinal fluid, excessive drainage and ventricular abnormalities. The result is neurological disorders. In addition, death is not excluded if the disconnection of the catheter is not detected.

Medtronic Duet products of series 46913, 46914, 46915, 46916 and 46917, which were delivered to the market from May 3, 2021 to January 9, 2024, are subject to recall. A total of 45,176 low-quality systems were shipped. As of March 2024, at least 26 incidents involving the use of defective products have been reported. At the same time, deaths were not recorded. Medtronic recommends that medical institutions check all components of the systems used for damage, as well as the reliability and tightness of the connections. Unused products must be returned to the manufacturer.^[1]

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