Brand

Medtronic Navigation, Inc. Recalls

56 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Medtronic Navigation, Inc..

56Total Recalls
5Critical
497,793Units Affected
Dec 4, 2024Most Recent
All Recalls

Every Medtronic Navigation, Inc. Recall

Sorted by most recent. Click any recall for full details.

56 recalls
High RiskFDA
Medtronic Navigation, Inc.
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percuta...
Medical Devices·67,370 affected·Dec 4, 2024
High RiskFDA
Medtronic Navigation, Inc.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is in...
Surgical Devices·1,801 affected·Aug 22, 2024
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Medical Devices·4,235 affected·Nov 28, 2023
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Medical Devices·4,224 affected·Nov 28, 2023
CriticalFDA
Medtronic Navigation, Inc.
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Medical Devices·746 affected·Apr 11, 2023
High RiskFDA
Medtronic Navigation, Inc.
AxiEM" Non-Invasive Patient Tracker
Medical Devices·1,867 affected·Dec 15, 2022
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue b...
Surgical Devices·95 affected·Oct 14, 2022
CriticalFDA
Medtronic Navigation, Inc.
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763...
Medical Devices·2,587 affected·Nov 11, 2021
High RiskFDA
Medtronic Navigation, Inc.
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bun...
Medical Devices·98 affected·Nov 9, 2021
High RiskFDA
Medtronic Navigation, Inc.
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locat...
Medical Devices·2 affected·Jun 5, 2020
High RiskFDA
Medtronic Navigation, Inc.
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Surgical Devices·177 affected·Dec 5, 2019
High RiskFDA
Medtronic Navigation, Inc.
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
Medical Devices·12 affected·Oct 30, 2019
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm...
Surgical Devices·4,654 affected·Jul 8, 2019
CriticalFDA
Medtronic Navigation, Inc.
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedu...
Medical Devices·5,487 affected·Sep 26, 2018
CriticalFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm T...
Cardiac Devices·1,283 affected·Mar 23, 2018
High RiskFDA
Medtronic Navigation, Inc.
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Str...
Surgical Devices·6 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70...
Surgical Devices·13 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Naviga...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The ...
Surgical Devices·60 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the ...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. Th...
Surgical Devices·75 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the S...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name ...
Surgical Devices·8 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Re...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450,...
Surgical Devices·15 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1...
Surgical Devices·214 affected·Jun 7, 2017
High RiskFDA
Medtronic Navigation, Inc.
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Medical Devices·108 affected·May 10, 2017
High RiskFDA
Medtronic Navigation, Inc.
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 car...
Medical Devices·111 affected·Dec 12, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouc...
Surgical Devices·100 affected·Sep 1, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches...
Surgical Devices·100 affected·Sep 1, 2016
High RiskFDA
Medtronic Navigation, Inc.
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visuala...
Cardiac Devices·120 affected·May 9, 2016
High RiskFDA
Medtronic Navigation, Inc.
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Ki...
Surgical Devices·4 affected·Feb 22, 2016
High RiskFDA
Medtronic Navigation, Inc.
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734...
Medical Devices·2,346 affected·Sep 14, 2015
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needl...
Medical Devices·1,415 affected·Jul 17, 2015
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. ...
Medical Devices·15,798 affected·May 26, 2015
High RiskFDA
Medtronic Navigation, Inc.
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RES. PACK 9733553 AxiEM S.M.
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
KIT, 9731427, THORACIC TACTILE PROBES
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801071 1/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
BIT 9733516 2.9mm DRILL STERILE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801075 5/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014