Medtronic Navigation, Inc.
59 recalls on record · Latest: Feb 5, 2025
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 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 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 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 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 Dec 18, 2019
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
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 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 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 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 May 25, 2016
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Ca…
FDA Devices Moderate Mar 30, 2016
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used du…
FDA Devices Moderate Oct 7, 2015
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA S…
FDA Devices Moderate Aug 12, 2015
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an acce…
FDA Devices Moderate Jul 8, 2015
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets con…
FDA Devices Moderate Nov 26, 2014
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
FDA Devices Moderate Nov 26, 2014
DRAPE 9732722 TUBE STERILE O-ARM 20PK
FDA Devices Moderate Nov 26, 2014
TUMOR RES. PACK 9733553 AxiEM S.M.
FDA Devices Moderate Nov 26, 2014
KIT, 9731427, THORACIC TACTILE PROBES
FDA Devices Moderate Nov 26, 2014
ENT PRGM 9734636 ADD FUSION NAV AxiEM
FDA Devices Moderate Nov 26, 2014
MOUSE 9732721 STERILE O-ARM 10PK
FDA Devices Moderate Nov 26, 2014
SPHERES 8801071 1/TRAY 12PK
FDA Devices Moderate Nov 26, 2014
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
FDA Devices Moderate Nov 26, 2014
BIT 9733516 2.9mm DRILL STERILE
FDA Devices Moderate Nov 26, 2014