The Recall Desk

Manufacturer

Medtronic Navigation, Inc.

91 recalls in our database name Medtronic Navigation, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
91
Critical
2
Severe
12
Most recent
2025-02-05

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.

About this listing

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.

1–25 of 91

  • HighFDA (Devices)·Z-1022-2025·2025-02-05

    Medtronic Percutaneous Reference Pins May Not Fit Properly

    Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.

    Product
    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 pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0050-2025·2024-10-16

    StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects

    Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1776-2024·2024-05-15

    Stealth S8 neurosurgical navigation software display error affecting surgical guidance

    Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2024·2024-01-17

    Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects

    Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.

    Product
    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2024·2024-01-17

    Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues

    Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.

    Product
    Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2024·2023-11-15

    StealthStation S8 Surgical Navigation System Software Anomaly Recall

    Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1666-2023·2023-06-14

    StealthStation Cranial Software displays inaccurate navigation during brain surgery

    A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.

    Product
    StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1630-2023·2023-06-14

    StealthStation Cranial Software Depth Gauge Synchronization Failure Risk

    A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.

    Product
    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2023·2023-02-08

    Non-Invasive Patient Tracker Verification Failure During Image-Guided Surgery

    Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.

    Product
    AxiEM" Non-Invasive Patient Tracker
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0953-2023·2023-01-18

    Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal

    Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.

    Product
    RadiaLux Lighted Retractor (Pink), REF: 50-101-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2023·2022-11-23

    Medtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall

    Medtronic is recalling 95 units of Visualase Cooled Laser Applicator System devices due to a defect in the outer pouch sterile seal. Affected devices were distributed nationwide to healthcare facilities.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0383-2022·2021-12-29

    Stealthstation and Synergy Cranial surgical navigation system software synchronization error

    Stealthstation and Synergy Cranial surgical navigation systems may display an incorrect biopsy needle position due to software synchronization failure. This could result in prolonged surgery, additional procedures, or tissue injury.

    Product
    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
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0417-2022·2021-12-29

    Surgical Navigation Tracker Subject to Weld Failure and Navigation Inaccuracy

    A surgical navigation tracker used in neurosurgery may experience weld failure, leading to navigation inaccuracy, prolonged procedure time, and potential tissue injury. 98 affected units were distributed across US and international healthcare facilities.

    Product
    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2707-2020·2020-08-05

    Medtronic StealthStation S7 System Recalled for Navigation Inaccuracy

    Medtronic is recalling two StealthStation S7 Systems with Polaris Spectra Cameras due to a manufacturing issue that may cause 6mm navigation inaccuracy when using specific trackers.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2330-2020·2020-06-17

    Medtronic Mazor X Surgical System Positioner Recalled for Detachment Risk

    Medtronic is recalling 177 Mazor X Surgical System Positioner Type II units because they may unexpectedly detach from the operating table, posing a risk of blunt injury to patients.

    Product
    Mazor X Surgical System Positioner Type II, REF: ASM0214-02
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1995-2020·2020-05-27

    Medtronic Nexframe Stereotactic System Recalled for Lead Placement Inaccuracies

    Medtronic is recalling the Nexframe Stereotactic System and specific software combinations due to potential inaccuracies in deep brain stimulation lead placement.

    Product
    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 the auto-registration (fiducial- less) workflow used in combi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2020·2020-05-13

    Medtronic Recalls Visualase Cooled Laser Applicator System Tubing Sets

    Medtronic is recalling Visualase Cooled Laser Applicator System tubing sets due to assembly defects that may disrupt saline flow.

    Product
    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
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1693-2020·2020-04-22

    Medtronic NavLock Tracker Recalled Due to Incorrect Assembly

    Medtronic Navigation is recalling one unit of the NavLock Tracker because incorrect assembly could affect navigation accuracy.

    Product
    NavLock Tracker *** Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0707-2020·2019-12-25

    Medtronic Percutaneous Pin Adapter Recall for Potential Rotation

    Medtronic is recalling 1,297 percutaneous pin adapters because they may rotate after surgical placement and fail to return to their original position.

    Product
    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 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percuta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0657-2020·2019-12-18

    Medtronic Passive Biopsy Needle Kit Recall for Depth Stop Issue

    Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.

    Product
    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0658-2020·2019-12-18

    Medtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue

    Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially delaying surgery.

    Product
    Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0659-2020·2019-12-18

    Medtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue

    Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially causing surgery delays.

    Product
    Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
    Category
    Medical Device
    Distribution
    49 states
  • CriticalFDA (Devices)·Z-0552-2019·2019-01-09

    Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error

    Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.

    Product
    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 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-3251-2018·2018-10-03

    Medtronic Visualase Thermal Therapy System Recalled for MR Thermometry Inaccuracy

    Medtronic is recalling Visualase Thermal Therapy System software due to potential MR thermometry inaccuracies that may cause unaccounted thermal energy spread during laser ablation.

    Product
    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2501-2018·2018-07-25

    Medtronic Recalls Visualase Cooled Laser Applicator Systems Due to Calibration Issues

    Medtronic is recalling 1,283 Visualase Cooled Laser Applicator Systems because calibration errors may cause low laser energy output or fiber burnout.

    Product
    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 Number 9735561 Visualase¿ Cooled Laser Applicator
    Category
    Medical Device
    Distribution
    Distributed nationwide