PlainRecalls

Medtronic Navigation, Inc.

Compiled from official public sources by the editorial team.

91 recalls on record · Latest: Feb 5, 2025

Medtronic Navigation, Inc. Recall Insight

Medtronic Navigation, Inc. appears on 91 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.089% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 5, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 7 critical, 43 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Aug 10, 2016 to Feb 5, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 5, 2025

Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Refere…

FDA Devices Moderate Oct 16, 2024

StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an…

FDA Devices Critical May 15, 2024

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structu…

FDA Devices Moderate Jan 17, 2024

Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS

FDA Devices Moderate Jan 17, 2024

Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS

FDA Devices Critical Nov 15, 2023

StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as…

FDA Devices Critical Jun 14, 2023

StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

FDA Devices Critical Jun 14, 2023

StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

FDA Devices Moderate Feb 8, 2023

AxiEM" Non-Invasive Patient Tracker

FDA Devices Moderate Jan 18, 2023

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

FDA Devices Moderate Nov 23, 2022

Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians…

FDA Devices Moderate Dec 29, 2021

Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguid…

FDA Devices Critical Dec 29, 2021

Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and Stealt…

FDA Devices Moderate Aug 5, 2020

StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomic…

FDA Devices Moderate Jun 17, 2020

Mazor X Surgical System Positioner Type II, REF: ASM0214-02

FDA Devices Critical May 27, 2020

Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 …

FDA Devices Moderate May 13, 2020

Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm …

FDA Devices Moderate Apr 22, 2020

NavLock Tracker *** Rx Only

FDA Devices Moderate Dec 25, 2019

Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: U…

FDA Devices Moderate Dec 18, 2019

Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

FDA Devices Moderate Dec 18, 2019

Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108

FDA Devices Moderate Dec 18, 2019

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

FDA Devices Critical Jan 9, 2019

StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using op…

FDA Devices Moderate Oct 3, 2018

Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

FDA Devices Moderate Jul 25, 2018

Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Pa…

FDA Devices Moderate Oct 25, 2017

VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visuala…

FDA Devices Moderate Sep 27, 2017

Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System,…

FDA Devices Moderate Sep 27, 2017

Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Refere…

FDA Devices Moderate Sep 27, 2017

Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referen…

FDA Devices Moderate Sep 27, 2017

Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fi…

FDA Devices Moderate Sep 27, 2017

Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing f…

FDA Devices Moderate Aug 30, 2017

Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suctio…

FDA Devices Moderate Aug 30, 2017

Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved …

FDA Devices Moderate Aug 30, 2017

Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devi…

FDA Devices Moderate Aug 30, 2017

Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction de…

FDA Devices Moderate Aug 30, 2017

Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label…

FDA Devices Moderate Aug 30, 2017

Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curv…

FDA Devices Moderate Aug 30, 2017

Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction dev…

FDA Devices Moderate Aug 30, 2017

Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devi…

FDA Devices Moderate Aug 2, 2017

Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Ca…

FDA Devices Moderate Jul 26, 2017

Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

FDA Devices Moderate Jan 18, 2017

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.

FDA Devices Moderate Nov 9, 2016

Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The pa…

FDA Devices Moderate Nov 9, 2016

Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packa…

FDA Devices Moderate Aug 10, 2016

S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usa…

FDA Devices Moderate Aug 10, 2016

FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The…

FDA Devices Moderate Aug 10, 2016

Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Us…

FDA Devices Moderate Aug 10, 2016

Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Produc…

FDA Devices Moderate Aug 10, 2016

Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: …

FDA Devices Moderate Aug 10, 2016

MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Prod…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Medtronic Navigation, Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.