Medtronic recalled two neurosurgery products so far in 2024.
1. Medtronic Neurosurgery issued a Class I recall affecting 45,176 Duet external drainage and monitoring system catheter tubing following 26 reported injuries. The recall impacts five product models, according to a March 7 FDA alert. The recall was initiated on Jan. 22. Medtronic Neurosurgery is recalling the Duet external drainage and monitoring system catheter tubing due to a potential for the catheter disconnection from the patient line stopcock connectors.
2. A Class I recall was issued for Medtronic's StealthStation System with StealthStation Cranial software, which is used for locating anatomical structures during neurosurgery. Medtronic has issued the recall for devices distributed between March 21, 2017, and March 22, 2024, according to a June 5 alert from the FDA. Medtronic is recalling the StealthStation S8 Application versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1. Customers complained that a software error was causing numbers or letters to be missing from the displayed text and replaced by a space in either the "distance to target" or "tip stop point" display during navigation.The missing number may result in the mechanical depth stop being set too short or too long, causing surgeons to use an incorrect measurement for placement of the biopsy tip stop during navigation.