Medtronic Navigation recalls
Medtronic Navigation appears in 92 official U.S. recall notices indexed by RecallRadar, most recently on 2025-02-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 92 |
|---|---|
| Published | 2012-06-27 to 2025-02-05 |
| By agency | FDA Device (92) |
| By classification | Class II (85), Class I (7) |
| By status | terminated (75), ongoing (17) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Re…
FDA Device · Class II · 2025-02-05 · Medtronic Navigation
Reason: Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. - StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intende…
FDA Device · Class II · 2024-10-16 · Medtronic Navigation
Reason: 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 th… - Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only
FDA Device · Class I · 2024-05-15 · Medtronic Navigation
Reason: 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. - Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation
Reason: 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. - Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation
Reason: 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. - StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is inte…
FDA Device · Class I · 2023-11-15 · Medtronic Navigation
Reason: Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. - StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
FDA Device · Class I · 2023-06-14 · Medtronic Navigation
Reason: 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 show… - StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
FDA Device · Class I · 2023-06-14 · Medtronic Navigation
Reason: 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 stimul… - AxiEM" Non-Invasive Patient Tracker
FDA Device · Class II · 2023-02-08 · Medtronic Navigation
Reason: 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. - RadiaLux Lighted Retractor (Pink), REF: 50-101-1
FDA Device · Class II · 2023-01-18 · Medtronic Navigation
Reason: Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. - Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product
FDA Device · Class II · 2022-11-23 · Medtronic Navigation
Reason: Due to a defect in the outer pouch sterile seal - Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundl…
FDA Device · Class II · 2021-12-29 · Medtronic Navigation
Reason: 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… - Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software
FDA Device · Class I · 2021-12-29 · Medtronic Navigation
Reason: 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… - StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locatin…
FDA Device · Class II · 2020-08-05 · Medtronic Navigation
Reason: 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. W… - Mazor X Surgical System Positioner Type II, REF: ASM0214-02
FDA Device · Class II · 2020-06-17 · Medtronic Navigation
Reason: 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, ble… - Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthS…
FDA Device · Class I · 2020-05-27 · Medtronic Navigation
Reason: 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 s… - Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.…
FDA Device · Class II · 2020-05-13 · Medtronic Navigation
Reason: 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… - NavLock Tracker *** Rx Only
FDA Device · Class II · 2020-04-22 · Medtronic Navigation
Reason: Product was incorrectly assembled which could affect navigation accuracy of the device. - Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following…
FDA Device · Class II · 2019-12-25 · Medtronic Navigation
Reason: 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… - Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
FDA Device · Class II · 2019-12-18 · Medtronic Navigation
Reason: 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 n… - Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
FDA Device · Class II · 2019-12-18 · Medtronic Navigation
Reason: 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 n… - Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
FDA Device · Class II · 2019-12-18 · Medtronic Navigation
Reason: 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 n… - StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures u…
FDA Device · Class I · 2019-01-09 · Medtronic Navigation
Reason: 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. - Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
FDA Device · Class II · 2018-10-03 · Medtronic Navigation
Reason: 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. - Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip
FDA Device · Class II · 2018-07-25 · Medtronic Navigation
Reason: 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 ca… - VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip
FDA Device · Class II · 2017-10-25 · Medtronic Navigation
Reason: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process. - Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Refer…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation
Reason: 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. - Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spi…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation
Reason: 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. - Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Refe…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation
Reason: 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. - Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spin…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation
Reason: 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. - Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigatio…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation
Reason: 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. - Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straig…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suct…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suc…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suc…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suct…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation
Reason: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. - Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1)…
FDA Device · Class II · 2017-08-02 · Medtronic Navigation
Reason: 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 sy… - Install CD, Spine tools, Plus and S7, Version 25
FDA Device · Class II · 2017-07-26 · Medtronic Navigation
Reason: 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 Elev… - AxIEM Touch N Go Pointer Probe
FDA Device · Class II · 2017-01-18 · Medtronic Navigation
Reason: 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 wit… - Visualase Body Accessory Kit PN 020-3000
FDA Device · Class II · 2016-11-09 · Medtronic Navigation
Reason: 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… - Visualase Visualization Stylets PN 020-2301
FDA Device · Class II · 2016-11-09 · Medtronic Navigation
Reason: 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… - Synergy Spine
FDA Device · Class II · 2016-08-10 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. - MACH Cranial Treon
FDA Device · Class II · 2016-08-10 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. - MACH AxiEM Cranial Treon
FDA Device · Class II · 2016-08-10 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. - Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes
FDA Device · Class II · 2016-08-10 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. - FrameLink
FDA Device · Class II · 2016-08-10 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. - S7 MACH FrameLink
FDA Device · Class II · 2016-08-10 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.