Manufacturer
91 recalls in our database name Medtronic Navigation, Inc. as the manufacturing or recalling firm.
Of the 91 recalls from Medtronic Navigation, Inc. we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (13%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 thoracic tactile probe kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 sterile O-Arm devices because returned units may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 AxIEM CR tumor resection devices because returned units may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units may not have been properly examined for damage to ensure sterility.
Medtronic is recalling O-arm Imaging Systems because a review found gaps in compliance with FDA labeling requirements for user information.
Medtronic Navigation is correcting Framelink software version 5.4 due to potential discrepancies between exam images and displayed measurements during surgical planning.
Medtronic is recalling 463 O-arm Imaging Systems worldwide due to a potential failure of the braking system controlling vertical gantry movement.
Medtronic is recalling 12 Vertex Max Drill Tubes due to a defect in the internal threading used for component setup.
Medtronic is recalling 17 O-arm Imaging Systems because a high voltage relay fault may cause overheating and burning.
Medtronic is recalling three 0-arm Imaging Systems because software version 3.1.1 does not meet navigational accuracy standards.