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Medtronic Navigation Recalls
92 recalls on record · June 27, 2012 to February 5, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 27, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation Sys
Hazard: 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.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 contai
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suc
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Loui
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Lo
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Lou
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 30, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Loui
Hazard: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
August 2, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um C
Hazard: 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 of the TBA.
July 26, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Hazard: 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.
January 18, 2017Medical DevicesFDA
Medtronic Navigation, Inc. recalls AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then plac
Hazard: 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.
November 9, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged
Hazard: 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.
November 9, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packa
Hazard: 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.
August 10, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for
Hazard: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
August 10, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipp
Hazard: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
August 10, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for s
Hazard: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
August 10, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping p
Hazard: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
August 10, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shippi
Hazard: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
August 10, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purpo
Hazard: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
August 10, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipp
Hazard: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
July 13, 2016Medical DevicesFDA
Medtronic Navigation recalls PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product T
Hazard: Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user.
May 25, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF
Hazard: Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
March 30, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization
Hazard: Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.
March 16, 2016Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system de
Hazard: Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality
October 7, 2015Medical DevicesFDA
Medtronic Navigation, Inc. recalls P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279,
Hazard: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
October 7, 2015Medical DevicesFDA
Medtronic Navigation, Inc. recalls 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, DR
Hazard: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
August 12, 2015Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Pas
Hazard: 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.
August 12, 2015Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy
Hazard: 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.
July 8, 2015Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective p
Hazard: 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.