Medtronic Navigation, Inc
FDA adverse event reports naming Medtronic Navigation, Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC NAVIGATION, INC.
- Total reports
- 25,090
- Deaths
- 72
- Injuries
- 1,116
- Malfunctions
- 23,902
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Neurological Stereotaxic InstrumentHAW21,075
- Orthopedic Stereotaxic InstrumentOLO1,965
- Ear, Nose, And Throat Stereotaxic InstrumentPGW1,131
- Powered Laser Surgical InstrumentGEX605
- Intervertebral Fusion Device With Bone Graft, LumbarMAX106
- Image-Intensified Fluoroscopic X-Ray System, MobileOXO99
- Interventional Fluoroscopic X-Ray SystemOWB36
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI33
- Stylet, Surgical, General & Plastic SurgeryGAH23
- Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT3
Recent recalls
- 2026-06-15Open, ClassifiedUnder Investigation by firm
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
- 2025-07-09Open, ClassifiedUnder Investigation by firm
O-arm O2 Imaging System. Mobile X-Ray System.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
- 2025-01-27Open, ClassifiedUnder Investigation by firm
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
- 2024-10-10Open, ClassifiedSoftware design
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
- 2024-06-06Open, ClassifiedDevice Design
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
- 2024-05-09Open, ClassifiedSoftware design
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
- 2024-01-10Open, ClassifiedDevice Design
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
- 2024-01-10Open, ClassifiedDevice Design
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
- 2023-11-10Open, ClassifiedSoftware design
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
- 2023-08-24Open, ClassifiedUnder Investigation by firm
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Ground cable installed incorrectly.
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