FDA Device Recalls

Recalls / Firms / Medtronic Navigation, Inc.

Medtronic Navigation, Inc.

108 FDA device recalls on record.

DateClassProductReason
2024-12-04Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS
2024-08-22StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with S
2024-03-26Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation
2023-11-28Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
2023-11-28Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
2023-09-27StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with
2023-04-11StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthSta
2023-04-11StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
2022-12-15AxiEM" Non-Invasive Patient Tracker
2022-12-08RadiaLux Lighted Retractor (Pink), REF: 50-101-1
2022-10-14Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to
2021-11-11Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software
2021-11-09Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instr
2020-06-05StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are i
2019-12-05Mazor X Surgical System Positioner Type II, REF: ASM0214-02
2019-10-30Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
2019-10-30Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
2019-10-30Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
2019-08-28NavLock Tracker *** Rx Only
2019-08-09Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with
2019-07-08Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.
2018-12-06Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 007
2018-09-26StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide
2018-06-01Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735
2018-03-23Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Co
2017-07-27VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicat
2017-06-29Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic
2017-06-29Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthSta
2017-06-29Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Na
2017-06-29Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic St
2017-06-29Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Na
2017-06-29Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which inc
2017-06-29Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Sm
2017-06-29Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic Ste
2017-06-29Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthSt
2017-06-29Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used wi
2017-06-29Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic N
2017-06-29Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9
2017-06-29Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containin
2017-06-07Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffu
2017-05-10Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
2016-12-12AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyv
2016-09-01Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Access
2016-09-01Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Acc
2016-07-18Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic wi
2016-07-18FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a labe
2016-07-18MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plas
2016-07-18Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plasti
2016-07-18Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a
2016-07-18S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic wit
2016-07-18MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic wi
2016-05-09Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser
2016-02-22BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for
2016-01-29Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobi
2015-09-14P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN
2015-09-14P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN
2015-07-17Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image gu
2015-07-17Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. T
2015-05-26Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube
2015-05-05Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540
2014-04-24SPHERES 8801071 1/TRAY 12PK
2014-04-24BIOPSY NEEDLE KIT, 9733068, PASSIVE
2014-04-24PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
2014-04-24PIN, 9733236, 150MM, STERILE, PERC REF
2014-04-24PACK 9731975 TUMOR RESECTION AXIEM CR
2014-04-24MOUSE 9732721 STERILE O-ARM 10PK
2014-04-24TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
2014-04-24UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
2014-04-24DRAPE 9732722 TUBE STERILE O-ARM 20PK
2014-04-24SPHERES 8801075 5/TRAY 12PK
2014-04-24ENT PRGM 9734636 ADD FUSION NAV AxiEM
2014-04-24DISP 9730950 STRL SPHERE, 1 PK INSERT
2014-04-24BAG 9732315 MOUSE STERILE 15 PK
2014-04-24INSTRUMENT TRACKER 9733533XOM ENT 1PK
2014-04-24BIT 9733516 2.9mm DRILL STERILE
2014-04-24PATIENT TRACKER 9733534XOM ENT 1PK
2014-04-24INST 9731132 KIT CR REF FRAME DRIVER 5PK
2014-04-24PIN, 9733235, 100MM, STERILE, PERC REF
2014-04-24TRAJ GUIDE KIT, 9733066, BIOPSY, INT
2014-04-24SHUNT KIT 9733605 NON-INVASIVE
2014-04-24TUMOR RES. PACK 9733553 AxiEM S.M.
2014-04-24DISP 9730951 STRL SPHERE, 5PK INSERT
2014-04-24KIT, 9731427, THORACIC TACTILE PROBES
2014-04-24TUMOR RESECTION KIT 9733608 SKULL MOUNT
2014-04-24TUMOR RESECTION KIT 9733607 NON-INVASIVE
2013-07-25Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-a
2013-07-15StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and plann
2013-01-31Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
2012-11-13The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 97333
2012-07-11Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-
2012-02-06Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand
2012-02-06Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable han
2011-06-02DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM
2011-01-20Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trac
2011-01-20Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Track
2010-12-22Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigat
2010-12-15Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide K
2010-11-05Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigati
2010-10-15Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Num
2010-10-12Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and B
2010-09-24Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surger
2010-06-14Medtronic StealthStation S7 System
2010-05-10O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applica
2009-11-03Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In co
2008-06-30BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human ana
2007-11-27Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
2007-10-17Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Li
2006-02-01AxiEM EM Knee Kit, and associated workstation.