Manufacturer

Medtronic Navigation, Inc.

91 recalls in our database name Medtronic Navigation, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 91
Critical: 2
Severe: 12
Most recent: 2025-02-05

Of the 91 recalls from Medtronic Navigation, Inc. we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (13%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 91

ModerateFDA (Devices)·Z-2317-2016·2016-08-10
Medtronic Navigation Recalls Fusion ENT Software Application
Medtronic Navigation is voluntarily recalling 27 units of the Fusion ENT software application due to a field action involving Neurologica scanners.
Product
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2016·2016-05-25
Medtronic Recalls Visualase Cooled Laser Applicator Systems Due to Melting Risk
Medtronic is recalling 120 Visualase Cooled Laser Applicator Systems because the catheters may melt during procedures.
Product
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue th
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1234-2016·2016-03-30
Medtronic Recalls BioTex Reusable Adapter Kits Lacking FDA Clearance
Medtronic Navigation is recalling four BioTex Reusable Adapter Kits because they were distributed without FDA 510(k) clearance.
Product
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1088-2016·2016-03-16
Medtronic O-arm O2 Imaging System Recalled for Loose Detector Panel Screws
Medtronic is recalling one O-arm O2 Imaging System unit in Austria because loose screws may cause the detector panel to contact other parts, leading to noise, vibration, and poor image quality.
Product
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 fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects wi
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2823-2015·2015-10-07
Medtronic Solera Screwdrivers Recalled for Tip Deformation Risk
Medtronic Navigation is recalling 2,346 Solera screwdrivers used in spine surgery because specific conditions may cause the tips to deform or break.
Product
P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. The Medtronic Navig
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2824-2015·2015-10-07
Medtronic Navigated Solera Screwdrivers Recalled for Potential Tip Deformation
Medtronic Navigation is recalling 2,346 Navigated Solera Screwdrivers used in spine surgery because specific use conditions may cause the tips to deform or break.
Product
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2325-2015·2015-08-12
Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect
Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.
Product
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2324-2015·2015-08-12
Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect
Medtronic is recalling 1,415 Passive Biopsy Needle Kits because compromised adhesive may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.
Product
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2015·2015-07-08
Medtronic Recalls Navigated Cannulated Taps Due to Cleaning Injury Risk
Medtronic Navigation is correcting 15,798 Navigated Cannulated Taps distributed worldwide due to a potential for injury during the cleaning process.
Product
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled a
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1794-2015·2015-06-24
Medtronic Passive Planar Blunt Probe Recalled Due to Sharp Tip Defect
Medtronic is recalling 18 Passive Planar Blunt Probes because they were manufactured with sharp tips instead of blunt tips. The devices are used in navigated surgery.
Product
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked,
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1595-2014·2014-11-26
Medtronic Recalls Single-Use Disposable Devices Due to Sterility Control Issues
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately examined for damage to ensure sterility.
Product
SPHERES 8801071 1/TRAY 12PK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1582-2014·2014-11-26
Medtronic Recalls Disposable Sterile Surgical Devices Due to Sterility Concerns
Medtronic Navigation is recalling 26,674 disposable sterile devices because returned units may not have been properly examined for damage that could compromise sterility.
Product
DISP 9730951 STRL SPHERE, 5PK INSERT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1579-2014·2014-11-26
Medtronic Recalls Biopsy Needle Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 biopsy needle kits because returned devices may not have been properly examined for damage to ensure sterility.
Product
BIOPSY NEEDLE KIT, 9733068, PASSIVE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1602-2014·2014-11-26
Medtronic Recalls Single-Use Navigation Devices Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 single-use, disposable navigation devices because returned units were not adequately examined for damage that could compromise sterility.
Product
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1583-2014·2014-11-26
Medtronic Recalls Sterile O-Arm Drapes Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.
Product
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1600-2014·2014-11-26
Medtronic Recalls Tumor Resection Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.
Product
TUMOR RESECTION KIT 9733607 NON-INVASIVE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1594-2014·2014-11-26
Medtronic Recalls Non-Invasive Shunt Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 non-invasive shunt kits because returned devices were not adequately inspected for damage that could compromise sterility.
Product
SHUNT KIT 9733605 NON-INVASIVE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1586-2014·2014-11-26
Medtronic Recalls Instrument Trackers Due to Sterility Control Issues
Medtronic Navigation is recalling single-use instrument trackers because returned devices may not have been properly examined for damage to ensure sterility.
Product
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1581-2014·2014-11-26
Medtronic Recalls Disposable Surgical Devices Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 single-use disposable devices because returned items were not adequately inspected for damage that could compromise sterility.
Product
DISP 9730950 STRL SPHERE, 1 PK INSERT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1585-2014·2014-11-26
Medtronic Recalls Single-Use Ref Frame Driver Kits Due to Sterility Concerns
Medtronic Navigation is recalling 26,674 single-use Ref Frame Driver Kits because returned devices may not have been properly examined for damage to ensure sterility.
Product
INST 9731132 KIT CR REF FRAME DRIVER 5PK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2014·2014-11-26
Medtronic Recalls Spine Pedicle Accessory Kits Due to Sterility Concerns
Medtronic Navigation is recalling 26,674 single-use spine pedicle accessory kits because returned devices may not have been properly examined for damage to ensure sterility.
Product
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1578-2014·2014-11-26
Medtronic Recalls Sterile Mouse Bags Due to Sterility Control Issues
Medtronic Navigation is recalling sterile mouse bags because returned devices may not have been properly examined for damage that could compromise sterility.
Product
BAG 9732315 MOUSE STERILE 15 PK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2014·2014-11-26
Medtronic Recalls Patient Tracker Devices Due to Sterility Control Issues
Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.
Product
PATIENT TRACKER 9733534XOM ENT 1PK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1593-2014·2014-11-26
Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.
Product
PIN, 9733236, 150MM, STERILE, PERC REF
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1592-2014·2014-11-26
Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.
Product
PIN, 9733235, 100MM, STERILE, PERC REF
Category
Medical Device
Distribution
Distributed nationwide