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.
- 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 - 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 - Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only
FDA Device · Class I · 2024-05-15 · Medtronic Navigation - Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - 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 - StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
FDA Device · Class I · 2023-06-14 · Medtronic Navigation - StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
FDA Device · Class I · 2023-06-14 · Medtronic Navigation - AxiEM" Non-Invasive Patient Tracker
FDA Device · Class II · 2023-02-08 · Medtronic Navigation - RadiaLux Lighted Retractor (Pink), REF: 50-101-1
FDA Device · Class II · 2023-01-18 · Medtronic Navigation - Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product
FDA Device · Class II · 2022-11-23 · Medtronic Navigation - 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 - 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 - 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 - Mazor X Surgical System Positioner Type II, REF: ASM0214-02
FDA Device · Class II · 2020-06-17 · Medtronic Navigation - 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 - 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 - NavLock Tracker *** Rx Only
FDA Device · Class II · 2020-04-22 · Medtronic Navigation - 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 - Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
FDA Device · Class II · 2019-12-18 · Medtronic Navigation - Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
FDA Device · Class II · 2019-12-18 · Medtronic Navigation - Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
FDA Device · Class II · 2019-12-18 · Medtronic Navigation - 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 - Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
FDA Device · Class II · 2018-10-03 · Medtronic Navigation - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - Install CD, Spine tools, Plus and S7, Version 25
FDA Device · Class II · 2017-07-26 · Medtronic Navigation - AxIEM Touch N Go Pointer Probe
FDA Device · Class II · 2017-01-18 · Medtronic Navigation - Visualase Body Accessory Kit PN 020-3000
FDA Device · Class II · 2016-11-09 · Medtronic Navigation - Visualase Visualization Stylets PN 020-2301
FDA Device · Class II · 2016-11-09 · Medtronic Navigation - Synergy Spine
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - MACH Cranial Treon
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - MACH AxiEM Cranial Treon
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - 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 - FrameLink
FDA Device · Class II · 2016-08-10 · Medtronic Navigation - S7 MACH FrameLink
FDA Device · Class II · 2016-08-10 · Medtronic Navigation