Medtronic Navigation, Inc.
91 recalls on record · Latest: Feb 5, 2025
Medtronic Navigation, Inc. Recall Insight
Medtronic Navigation, Inc. appears on 91 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.089% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 5, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 41 entries, severity tagging shows 0 critical, 41 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 41 of 41 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (41). The date window on this page runs from Jun 27, 2012 to Aug 10, 2016.
Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Us…
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Ca…
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used du…
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 an…
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA S…
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 R…
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an acce…
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instr…
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets con…
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the…
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
DRAPE 9732722 TUBE STERILE O-ARM 20PK
TUMOR RES. PACK 9733553 AxiEM S.M.
KIT, 9731427, THORACIC TACTILE PROBES
ENT PRGM 9734636 ADD FUSION NAV AxiEM
MOUSE 9732721 STERILE O-ARM 10PK
SPHERES 8801071 1/TRAY 12PK
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
BIT 9733516 2.9mm DRILL STERILE
SPHERES 8801075 5/TRAY 12PK
TUMOR RESECTION KIT 9733607 NON-INVASIVE
SHUNT KIT 9733605 NON-INVASIVE
INSTRUMENT TRACKER 9733533XOM ENT 1PK
DISP 9730950 STRL SPHERE, 1 PK INSERT
TRAJ GUIDE KIT, 9733066, BIOPSY, INT
PIN, 9733236, 150MM, STERILE, PERC REF
TUMOR RESECTION KIT 9733608 SKULL MOUNT
INST 9731132 KIT CR REF FRAME DRIVER 5PK
BIOPSY NEEDLE KIT, 9733068, PASSIVE
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
PATIENT TRACKER 9733534XOM ENT 1PK
PIN, 9733235, 100MM, STERILE, PERC REF
BAG 9732315 MOUSE STERILE 15 PK
PACK 9731975 TUMOR RESECTION AXIEM CR
DISP 9730951 STRL SPHERE, 5PK INSERT
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 des…
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutane…
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
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…
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…
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 m…
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Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.