Data / Medical devices / United States / Medtronic Navigation, Inc.
Medtronic Navigation, Inc.: FDA-registered device maker in Lafayette, CO, United States, 103 510(k) clearances
Medtronic Navigation, Inc. is registered with the FDA (registration 1723170) in Lafayette, CO, United States. It lists 25 device types. The FDA files 103 510(k) clearances under its listings, the newest dated March 26, 2026. 58 recall events name it as the recalling firm (7 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1723170
- FEI number
- 1000517638
- Address
- 200 Medtronic Drive, Lafayette, CO, United States, 80026
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 21, 1992
- Registered through
- 2027
- Brand names listed
- AEX Generator Refurbished, AQUAMANTYS SS4 BIPOLAR SEALER, MODEL 23-121-1, Aquamantys 2.3 Bipolar Sealer (23-113-1);, Aquamantys Epidural Vein Sealer (23-121-1), Aquamantys Mini EVS 3.4 Epidural Vein Sealer (23-314-1), Aquamantys SBS 5 Sheathed Bipolar Sealer (23-312-1), CD HORIZON SOLERA Spinal System, DBS Tunneling tool and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 103.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 26, 2026 | K253379 | Stealth AXiS Cranial clinical application | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 16, 2026 | K253395 | Stealth AXiS ENT clinical application | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 13, 2026 | K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | ONO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| February 12, 2026 | K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| September 11, 2025 | K251316 | Mazor X System / Mazor X Stealth Edition | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| June 5, 2025 | K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 29, 2025 | K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | ONO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| June 21, 2024 | K240465 | O-arm O2 Imaging System | OWB | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| October 19, 2023 | K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| April 7, 2023 | K230064 | Mazor X System (Mazor X Stealth Edition) | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| June 10, 2022 | K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| January 7, 2022 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | ONO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| December 22, 2021 | K212397 | StealthStation S8 Cranial v2.0 | HAW | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| July 8, 2021 | K211442 | StealthStation Spinous Process Clamps | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| January 13, 2021 | K203639 | StealthStation Cranial Software v1.3.2 | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| October 27, 2020 | K203005 | Mazor X | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| June 26, 2020 | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| June 18, 2020 | K201327 | NavLock Trackers | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| June 3, 2020 | K201175 | StealthStation Cranial Software v1.3.0 | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 29, 2020 | K201189 | Stealthstation S8 Spine Software v1.3.0 | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| April 24, 2020 | K200074 | O-arm O2 Imaging System | OWB | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 24, 2020 | K193579 | PlasmaBlade X 3.0S LIGHT | GEI | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| November 1, 2019 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| July 31, 2019 | K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 6, 2019 | K181859 | Visualase Thermal Therapy System | LLZ | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| November 2, 2018 | K182104 | NavLock Trackers, Robotic Reference Frame | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| August 2, 2018 | K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| July 11, 2018 | K180816 | Ziehm RFD 3D Tracker | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| September 7, 2017 | K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| July 3, 2017 | K171267 | NavLock Trackers | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| May 19, 2017 | K170018 | StealthStationTM S8 ENT Software | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 1, 2017 | K170011 | StealthStation S8 Spine Software v1.0.0 | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| April 21, 2017 | K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 31, 2017 | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 20, 2017 | K170296 | CoreCath 2.7S | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| December 30, 2016 | K162604 | Cranial Reducing Tubes | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| September 14, 2016 | K153660 | StealthStation System with Cranial Software | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| April 7, 2016 | K153555 | EM ENT Navigated Suctions | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| February 18, 2016 | K153247 | Fusion Compact Navigation System | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| August 6, 2015 | K151000 | O-Arm O2 Imaging System | OWB | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 11, 2015 | K150216 | Synergy Cranial | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 21, 2015 | K150297 | PlasmaBlade UPPP and Suction Coagulator | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| March 25, 2015 | K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143628 | Navigated Vertex Select Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 31, 2014 | K143175 | AEx Generator; PlasmaBlade T | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| July 25, 2014 | K133444 | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 22, 2014 | K140454 | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 13, 2014 | K133665 | MALLEABLE SUCTION INSTRUMENTS | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| December 3, 2013 | K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR | GEI | Substantially Equivalent | Medtronic Advanced Energy, LLC | accessdata.fda.gov |
| August 14, 2013 | K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| August 7, 2013 | K130608 | QUADCUT | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 22, 2013 | K124004 | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| January 10, 2013 | K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER | GEI | Substantially Equivalent | Medtronic Advanced Energy, LLC | accessdata.fda.gov |
| May 27, 2011 | K103775 | PEAK SUCTION COAGULATOR | GEI | Substantially Equivalent | Peak Surgical, Inc. | accessdata.fda.gov |
| April 5, 2011 | K101057 | AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 | GEI | Substantially Equivalent | Salient Surgical Technologies | accessdata.fda.gov |
| December 17, 2010 | K102709 | PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | Peak Surgical, Inc. | accessdata.fda.gov |
| December 16, 2010 | K102029 | PEAK PULSAR II GENERATOR MODEL PS100-102 | GEI | Substantially Equivalent | Peak Surgical, Inc. | accessdata.fda.gov |
| June 17, 2010 | K092564 | O-ARM IMAGING SYSTEM | OXO | Substantially Equivalent | Medtronic Navigation, Inc. (Littleton) | accessdata.fda.gov |
| April 13, 2010 | K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | Peak Surgical, Inc. | accessdata.fda.gov |
| March 16, 2010 | K092308 | POLESTAR, MODEL N-30 | LNH | Substantially Equivalent | Medtronic Navigation Israel, Ltd. | accessdata.fda.gov |
| June 5, 2009 | K083415 | PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | Peak Surgical, Inc. | accessdata.fda.gov |
| December 5, 2008 | K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| December 3, 2008 | K082786 | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES | GEI | Substantially Equivalent | Peak Surgical, Inc. | accessdata.fda.gov |
| September 10, 2008 | K081656 | VISUALASE THERMAL THERAPY SYSTEM | LLZ | Substantially Equivalent | Biotex, Inc. | accessdata.fda.gov |
| July 18, 2008 | K081512 | STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE | LLZ | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| January 9, 2008 | K073495 | TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT | GEI | Substantially Equivalent | Tissuelink Medical, Inc. | accessdata.fda.gov |
| February 22, 2007 | K063639 | AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 | GEI | Substantially Equivalent | Tissuelink Medical, Inc. | accessdata.fda.gov |
| August 31, 2006 | K061248 | AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 29, 2006 | K060344 | O-ARM IMAGING SYSTEM | OXO | Substantially Equivalent | Breakaway Imaging, LLC | accessdata.fda.gov |
| March 2, 2006 | K052623 | IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 1, 2006 | K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM | GEX | Substantially Equivalent | Biotex, Inc. | accessdata.fda.gov |
| October 25, 2005 | K052859 | AQUAMANTYS PUMP GENERATOR SYSTEM | GEI | Substantially Equivalent | Tissuelink Medical, Inc. | accessdata.fda.gov |
| July 27, 2005 | K050651 | MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| June 8, 2005 | K051029 | STELTHSTATION WIRELESS SURGEON MOUSE | HAW | Substantially Equivalent | Medtronic Surgical Navigation | accessdata.fda.gov |
| June 2, 2005 | K050438 | STEALTHSTATION SYSTEM UPDATE | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| May 5, 2005 | K050996 | O-ARM IMAGING SYSTEM | OXO | Substantially Equivalent | Breakaway Imaging, LLC | accessdata.fda.gov |
| March 18, 2005 | K050237 | STARSHIELD V3 RF TRNT | LNH | Substantially Equivalent | Odin Medical Technologies , Ltd. | accessdata.fda.gov |
| January 5, 2005 | K043088 | MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| January 27, 2004 | K033621 | NDI PASSIVE SPHERES | HAW | Substantially Equivalent | Northern Digital, Inc. | accessdata.fda.gov |
| September 12, 2003 | K032541 | POLESTAR N-20 | LNH | Substantially Equivalent | Odin Medical Technologies , Ltd. | accessdata.fda.gov |
| March 19, 2003 | K030552 | IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| February 12, 2003 | K030106 | STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| January 3, 2003 | K022126 | CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| November 19, 2002 | K021980 | HIP MODULE FOR THE STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| August 14, 2002 | K022414 | STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| March 27, 2002 | K014260 | TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE | GEI | Substantially Equivalent | Tissuelink Medical, Inc. | accessdata.fda.gov |
| January 25, 2002 | K012937 | KNEE MODULE FOR THE STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| April 27, 2001 | K010662 | MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL | GEI | Substantially Equivalent | Tissuelink Medical, Inc. | accessdata.fda.gov |
| June 30, 2000 | K001801 | STEATHSTATION TREATMENT GUIDANCE PLATFORM | HAW | Substantially Equivalent | Medtronic Surgical Navigation | accessdata.fda.gov |
| June 12, 2000 | K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| May 3, 2000 | K001153 | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM | HAW | Substantially Equivalent | Medtronic Surgical Navigation | accessdata.fda.gov |
| December 29, 1999 | K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| July 6, 1999 | K991468 | IMMERGE IMAGE CORRELATION | LLZ | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| April 22, 1999 | K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| January 14, 1999 | K983670 | STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| November 23, 1998 | K981768 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| January 21, 1998 | K974187 | STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| December 18, 1997 | K974638 | STERITITE SEALED CONTAINERS MODEL SCO4Q | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| November 21, 1997 | K974161 | STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| September 16, 1997 | K972398 | STEALTHSTATION PASSIVE INSTRUMENT OPTION | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 31, 2026 | 99895 | Class II | Ongoing | Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres. | accessdata.fda.gov |
| December 4, 2024 | 95970 | Class II | Ongoing | 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 i | Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. | accessdata.fda.gov |
| August 22, 2024 | 95283 | Class II | Ongoing | 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 percut | 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 sys | accessdata.fda.gov |
| March 26, 2024 | 94411 | Class I | Ongoing | 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. | accessdata.fda.gov |
| November 28, 2023 | 93611 | Class II | Ongoing | 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. | accessdata.fda.gov |
| September 27, 2023 | 93158 | Class I | Ongoing | 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 | Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. | accessdata.fda.gov |
| April 11, 2023 | 92269 | Class I | Ongoing | StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolo | accessdata.fda.gov |
| April 11, 2023 | 92141 | Class I | Ongoing | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury | accessdata.fda.gov |
| December 15, 2022 | 91354 | Class II | Ongoing | AxiEM" Non-Invasive Patient Tracker | Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery. | accessdata.fda.gov |
| December 8, 2022 | 91328 | Class II | Ongoing | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. | accessdata.fda.gov |
| October 14, 2022 | 91041 | Class II | Ongoing | Visualase Cooled Laser Applicator System (VCLAS) 9735560.4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures. | Due to a defect in the outer pouch sterile seal | accessdata.fda.gov |
| November 11, 2021 | 89058 | Class I | Ongoing | Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585 | Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury. | accessdata.fda.gov |
| November 9, 2021 | 89074 | Class II | Ongoing | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit. | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm The Bundle Autoguide Reg Kit does not have a model nu | accessdata.fda.gov |
| June 5, 2020 | 85901 | Class II | Terminated | StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. | There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, i | accessdata.fda.gov |
| December 5, 2019 | 85387 | Class II | Ongoing | Mazor X Surgical System Positioner Type II, REF: ASM0214-02 | There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)] | accessdata.fda.gov |
| October 30, 2019 | 84191 | Class II | Ongoing | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery. | accessdata.fda.gov |
| August 28, 2019 | 85318 | Class II | Terminated | NavLock Tracker *** Rx Only | Product was incorrectly assembled which could affect navigation accuracy of the device. | accessdata.fda.gov |
| August 9, 2019 | 85243 | Class I | Terminated | Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing th | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the sof | accessdata.fda.gov |
| July 8, 2019 | 85354 | Class II | Terminated | Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter | The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow. | accessdata.fda.gov |
| December 6, 2018 | 84045 | Class II | Terminated | Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 97 | Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure. | accessdata.fda.gov |
| September 26, 2018 | 81214 | Class I | Terminated | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue. | accessdata.fda.gov |
| June 1, 2018 | 80308 | Class II | Terminated | Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542 | Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue. | accessdata.fda.gov |
| March 23, 2018 | 80481 | Class II | Terminated | Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase Cooled Laser Applicator System 10mm Tip; c. Part Num | Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the potential for low laser energy output from fiber or fiber burnout at lower wattage. | accessdata.fda.gov |
| July 27, 2017 | 77977 | Class II | Terminated | VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase | The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process. | accessdata.fda.gov |
| June 29, 2017 | 77894 | Class II | Terminated | Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage. | accessdata.fda.gov |
| June 29, 2017 | 77739 | Class II | Terminated | Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with t | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. | accessdata.fda.gov |
| June 7, 2017 | 77623 | Class II | Terminated | Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Ba | Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out | accessdata.fda.gov |
| May 10, 2017 | 77354 | Class II | Terminated | Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. | Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures. | accessdata.fda.gov |
| December 28, 2016 | 76130 | Class II | Terminated | Intact Disposable Wands (part of the Intact System) : 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete re | Product sterility compromised due to breach of sterile barrier | accessdata.fda.gov |
| December 12, 2016 | 76060 | Class II | Terminated | AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton. | Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation System with Touch N Go Pointer Probes for patient registration. | accessdata.fda.gov |
| September 1, 2016 | 75124 | Class II | Terminated | Visualase Visualization Stylets PN. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Bod | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field. | accessdata.fda.gov |
| July 18, 2016 | 74715 | Class II | Terminated | Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. | accessdata.fda.gov |
| May 9, 2016 | 74096 | Class II | Terminated | Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indi | Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures. | accessdata.fda.gov |
| February 22, 2016 | 73337 | Class II | Terminated | BioTex Reusable Adapter Kit, Part Number, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of a | Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA. | accessdata.fda.gov |
| September 14, 2015 | 72183 | Class II | Terminated | P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,D | Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. | accessdata.fda.gov |
| July 17, 2015 | 71756 | Class II | Terminated | Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be | The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window in the brain. | accessdata.fda.gov |
| May 26, 2015 | 71342 | Class II | Terminated | Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies | Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps. | accessdata.fda.gov |
| May 5, 2015 | 71278 | Class II | Terminated | Medtronic Passive Planar Blunt Probe Part Number, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The | Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. | accessdata.fda.gov |
| April 24, 2014 | 68145 | Class II | Terminated | BAG 9732315 MOUSE STERILE 15 PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. | accessdata.fda.gov |
| November 12, 2013 | 66835 | Class II | Terminated | Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and sali | The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use. | accessdata.fda.gov |
| July 15, 2013 | 65743 | Class II | Terminated | StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. | Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use. | accessdata.fda.gov |
| November 13, 2012 | 63722 | Class II | Terminated | The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System t | Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up. | accessdata.fda.gov |
| February 6, 2012 | 61173 | Not yet classified | Terminated | Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with t | When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra. | accessdata.fda.gov |
| June 2, 2011 | 54621 | Not yet classified | Terminated | DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthStation systems. Produc | Software allows incorrect patient or patient history to be displayed. | accessdata.fda.gov |
| January 20, 2011 | 57858 | Not yet classified | Terminated | Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunctio | Distal end of tactile probe may break off during use. | accessdata.fda.gov |
| December 22, 2010 | 57696 | Not yet classified | Terminated | Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 Syst | Position Sensor Unit may generate tracking errors or may stop tracking immediately. | accessdata.fda.gov |
| December 15, 2010 | 57549 | Not yet classified | Terminated | Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. Used in conjunction with the StealthStation navigation syst | Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery. | accessdata.fda.gov |
| November 5, 2010 | 57277 | Not yet classified | Terminated | Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely locating anatomical structures in either open or percutaneous | Electronic surgical navigation aid may lose tracking ability or stop working. | accessdata.fda.gov |
| September 24, 2010 | 56893 | Not yet classified | Terminated | Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. To be used with a Medtronic Computer-Assisted Surg | Drill guide handle may detach unintentionally during use. | accessdata.fda.gov |
| June 14, 2010 | 56013 | Not yet classified | Terminated | Medtronic StealthStation S7 System | Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock. | accessdata.fda.gov |
| November 3, 2009 | 54381 | Not yet classified | Terminated | Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the location of an acetabular | Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed. | accessdata.fda.gov |
| November 27, 2007 | 45967 | Not yet classified | Terminated | Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 | Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker. | accessdata.fda.gov |
| October 17, 2007 | 45492 | Not yet classified | Terminated | Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0) | Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur) | accessdata.fda.gov |
| February 1, 2006 | 34604 | Not yet classified | Terminated | AxiEM EM Knee Kit, and associated workstation. | Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery. | accessdata.fda.gov |
| February 7, 2005 | 31132 | Not yet classified | Terminated | Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1 | The tip may separate from the device and render it unusable | accessdata.fda.gov |
| January 28, 2005 | 31133 | Not yet classified | Terminated | Stealth Station Cranial Application v.4.5 | The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. | accessdata.fda.gov |
| July 22, 2004 | 29697 | Not yet classified | Terminated | ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1,an accessory used with the TissueLink BiPolar Floating Device | Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing. | accessdata.fda.gov |
| October 31, 2003 | 27734 | Not yet classified | Terminated | Fix pins associated with Stealth Station Treatment Guidance Platform | Surgical devices intended for single use were not labeled for single use. | accessdata.fda.gov |
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Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.