PlainRecalls

Medtronic Navigation, Inc.

Compiled from official public sources by the editorial team.

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.

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 Us…

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 Ca…

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 du…

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 an…

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 S…

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 R…

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 acce…

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 instr…

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 con…

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…

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 des…

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 percutane…

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…

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…

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 m…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

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.