Medtronic Navigation recalls
Medtronic Navigation appears in 92 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Fusion ENT Application
FDA Device · Class II · 2016-08-10 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. - PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical M…
FDA Device · Class II · 2016-07-13 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user. - Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase…
FDA Device · Class II · 2016-05-25 · Medtronic Navigation
Reason: Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures. - BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is…
FDA Device · Class II · 2016-03-30 · Medtronic Navigation
Reason: Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA. - Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoros…
FDA Device · Class II · 2016-03-16 · Medtronic Navigation
Reason: Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could… - P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS
FDA Device · Class II · 2015-10-07 · Medtronic Navigation
Reason: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. - P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST
FDA Device · Class II · 2015-10-07 · Medtronic Navigation
Reason: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. - Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit
FDA Device · Class II · 2015-08-12 · Medtronic Navigation
Reason: The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the ne… - Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit
FDA Device · Class II · 2015-08-12 · Medtronic Navigation
Reason: The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the ne… - Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps
FDA Device · Class II · 2015-07-08 · Medtronic Navigation
Reason: Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps. - Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935
FDA Device · Class II · 2015-06-24 · Medtronic Navigation
Reason: Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. - ENT PRGM 9734636 ADD FUSION NAV AxiEM
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - BIOPSY NEEDLE KIT, 9733068, PASSIVE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - PACK 9731975 TUMOR RESECTION AXIEM CR
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - KIT, 9731427, THORACIC TACTILE PROBES
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - DISP 9730951 STRL SPHERE, 5PK INSERT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - TUMOR RESECTION KIT 9733607 NON-INVASIVE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - BAG 9732315 MOUSE STERILE 15 PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - PATIENT TRACKER 9733534XOM ENT 1PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - DISP 9730950 STRL SPHERE, 1 PK INSERT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - MOUSE 9732721 STERILE O-ARM 10PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - TUMOR RES. PACK 9733553 AxiEM S.M
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - INSTRUMENT TRACKER 9733533XOM ENT 1PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - DRAPE 9732722 TUBE STERILE O-ARM 20PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - PIN, 9733235, 100MM, STERILE, PERC REF
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - TRAJ GUIDE KIT, 9733066, BIOPSY, INT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - SHUNT KIT 9733605 NON-INVASIVE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - TUMOR RESECTION KIT 9733608 SKULL MOUNT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - PIN, 9733236, 150MM, STERILE, PERC REF
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - SPHERES 8801075 5/TRAY 12PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - BIT 9733516 2.9mm DRILL STERILE
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - SPHERES 8801071 1/TRAY 12PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - INST 9731132 KIT CR REF FRAME DRIVER 5PK
FDA Device · Class II · 2014-11-26 · Medtronic Navigation
Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package… - Medtronic O-arm Imaging System Mobile X-ray system
FDA Device · Class II · 2014-03-12 · Medtronic Navigation
Reason: Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be pr… - StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and per…
FDA Device · Class II · 2013-08-21 · Medtronic Navigation
Reason: Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the p… - Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
FDA Device · Class II · 2013-03-20 · Medtronic Navigation
Reason: Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction - The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370)
FDA Device · Class II · 2012-12-05 · Medtronic Navigation
Reason: Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up. - Medtronic O-arm¿ Imaging System
FDA Device · Class II · 2012-08-29 · Medtronic Navigation
Reason: A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn. - Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120
FDA Device · Class II · 2012-06-27 · Medtronic Navigation
Reason: Software Version 3.1.1 does not meet navigational accuracy.