Home Medizin Rückruf der Klasse I von Medtronic Duet EDMS-Katheterschläuchen

Rückruf der Klasse I von Medtronic Duet EDMS-Katheterschläuchen

von NFI Redaktion

Medtronic Neurosurgery has issued a recall of the catheter tubing of the Duet External Drainage and Monitoring System (EDMS) due to the possibility of the catheter detaching from the patient line stopcock connections.

If this occurs, infections, cerebrospinal fluid leakage, overdrainage of cerebrospinal fluid, and ventricular anomalies can potentially lead to harm for the patient. Uncontrolled overdrainage of cerebrospinal fluid can result in neurological damage or death if the interruption goes unnoticed.

The FDA has classified this as a Class I recall – the most serious type – due to the risk of severe injury or death. To date, 26 injuries have been reported, with no fatalities associated with this issue.

The recall affects 45,176 devices with model numbers 46913, 46914, 46915, 46916, and 46917, distributed in the US between May 3, 2021, and January 9, 2024.

The Duet EDMS is used for temporary cerebrospinal fluid drainage or sampling in patients undergoing surgery for an open descending thoracic aortic aneurysm (TAA) or descending thoracoabdominal aortic aneurysm (TAAA), or in patients undergoing TAA/TAAA repair surgery who develop symptoms such as spinal cord injury.

Medtronic has sent an urgent medical device recall letter to all affected customers, requesting them to identify, quarantine, and return all unused recalled products.

Customers are also advised to inspect all Duet EDMS components for damage and ensure all connections are secure and leak-free.

If a patient is currently connected to an affected Duet EDMS and a leak or interruption is identified, the device should be replaced with a new alternative device using sterile technique.

It is not recommended to remove or replace a Duet system device connected to a patient that is functioning as intended.

Customers in the US with questions regarding this recall should contact Medtronic at 1-800-874-5797.

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