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Medtronic recalls more than 45,000 catheter tubing units following injury reports

Medtronic is recalling over 45,000 cerebrospinal fluid (CSF) drainage and sampling tubes in the U.S. due to issues linked to 26 injuries. The FDA categorized the recall of the Duet External Drainage and Monitoring System as Class I, citing potential disconnections leading to infections, leakage, excessive CSF drainage, and abnormal ventricle conditions. Used during open surgery for aortic aneurysms or in post-procedure patients with symptoms like leg paralysis, the system faces disconnection risks from patient line stopcock connectors. Medtronic issued an urgent recall in January, urging identifying, quarantining, and returning affected products. Healthcare professionals are advised to check for damage, ensure secure connections, and switch to alternatives if issues arise. Medtronic advises against removing or replacing properly functioning Duet devices. This echoes a prior Class I recall, nearly a decade ago, warning of potential patient line tubing disconnections in the Duet system.