Medtronic Navigation, Inc.
91 recalls on record · Latest: Feb 5, 2025
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Agency notice ledger
Federal filing book Medtronic Navigation, Inc. MID-BOOK · SINGLE-AGENCY
#189 of 14,151 · 91 notices · 0.087% archive
- BOOK 91 notices
- RANK #189 of 14,151
- SHARE 0.087% archive
- AGENCY FDA Devices (91)
- CAT medical devices
- CATS 1 category
- LATEST Feb 5, 2025
- PHOTO American Surgical Com…
Nearest notice-volume peer: American Surgical Company (0 notice gap)
Medtronic Navigation, Inc. accounts for about 0.087% of the 104,423-notice archive on 91 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
How Medtronic Navigation, Inc. compares to 14,151 recalling firms
Medtronic Navigation, Inc. ranks 189th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Medtronic Navigation, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
91 189th of 14151 higher than 13,959 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Medtronic Navigation, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Medtronic Nav… (this)
Medtronic Navigation, Inc.
91 notices
- American Surg…
American Surgical Company
91 notices
- ConMed Corpor…
ConMed Corporation
91 notices
- Gills Onions,…
Gills Onions, LLC
91 notices
- Mack
Mack
91 notices
- The Kroger Co
The Kroger Co
91 notices
What this shows Medtronic Navigation, Inc. holds about 0.087% of archive notices alongside 91 distinct filings.
FDA Devices Moderate Aug 10, 2016
MACH Cranial Treon. 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 percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod,
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 Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenter
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 during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.
FDA Devices Moderate Mar 16, 2016
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 with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
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 STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
FDA Devices Moderate Oct 7, 2015
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 Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
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 accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
FDA Devices Moderate Aug 12, 2015
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.
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 contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surg
FDA Devices Moderate Jun 24, 2015
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, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
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
SPHERES 8801075 5/TRAY 12PK
FDA Devices Moderate Nov 26, 2014
TUMOR RESECTION KIT 9733607 NON-INVASIVE
FDA Devices Moderate Nov 26, 2014
SHUNT KIT 9733605 NON-INVASIVE
FDA Devices Moderate Nov 26, 2014
INSTRUMENT TRACKER 9733533XOM ENT 1PK
FDA Devices Moderate Nov 26, 2014
DISP 9730950 STRL SPHERE, 1 PK INSERT
FDA Devices Moderate Nov 26, 2014
TRAJ GUIDE KIT, 9733066, BIOPSY, INT
FDA Devices Moderate Nov 26, 2014
PIN, 9733236, 150MM, STERILE, PERC REF
FDA Devices Moderate Nov 26, 2014
TUMOR RESECTION KIT 9733608 SKULL MOUNT
FDA Devices Moderate Nov 26, 2014
INST 9731132 KIT CR REF FRAME DRIVER 5PK
FDA Devices Moderate Nov 26, 2014
BIOPSY NEEDLE KIT, 9733068, PASSIVE
FDA Devices Moderate Nov 26, 2014
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
FDA Devices Moderate Nov 26, 2014
PATIENT TRACKER 9733534XOM ENT 1PK
FDA Devices Moderate Nov 26, 2014
PIN, 9733235, 100MM, STERILE, PERC REF
FDA Devices Moderate Nov 26, 2014
BAG 9732315 MOUSE STERILE 15 PK
FDA Devices Moderate Nov 26, 2014
PACK 9731975 TUMOR RESECTION AXIEM CR
FDA Devices Moderate Nov 26, 2014
DISP 9730951 STRL SPHERE, 5PK INSERT
FDA Devices Moderate Mar 12, 2014
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm 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 with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
FDA Devices Moderate Aug 21, 2013
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
FDA Devices Moderate Mar 20, 2013
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
FDA Devices Moderate Dec 5, 2012
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .
FDA Devices Moderate Aug 29, 2012
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
FDA Devices Moderate Jun 27, 2012
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Medtronic Navigation, Inc. carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (91 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Medtronic Navigation, Inc.? ▼
PlainRecalls indexes 91 distinct federal recall events naming Medtronic Navigation, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Medtronic Navigation, Inc. sit among other recalling firms? ▼
Medtronic Navigation, Inc. ranks #189 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Medtronic Navigation, Inc.'s notices? ▼
FDA Devices accounts for 91 of this firm's 91 indexed notices.
What product category dominates Medtronic Navigation, Inc.'s filing book? ▼
Filings for Medtronic Navigation, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Medtronic Navigation, Inc.: 91 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Medtronic Navigation, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026