Medtronic Navigation, Inc. recalls
Every recall we track for Medtronic Navigation, Inc. — 44 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Medtronic Navigation, Inc. peaked in 2017 (15); 44 since 2017. 9% rated “stop using now”.
All FDA recall records for Medtronic Navigation, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 3 | 5 | 7 | 0 | 15 |
| 2018 | 0 | 2 | 2 | 0 | 4 |
| 2019 | 1 | 2 | 4 | 0 | 7 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 2 | 0 | 0 | 2 |
| 2022 | 0 | 0 | 2 | 1 | 3 |
| 2023 | 0 | 2 | 3 | 0 | 5 |
| 2024 | 0 | 0 | 3 | 0 | 3 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 4 | 4 |
What to do if you have a recalled Medtronic Navigation, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medtronic Navigation, Inc. recalls
27 shown- UnratedMedical device
Medtronic Navigation, Inc. recalls Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Medtronic Navigation, Inc.Aug 31, 2026 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The
Medtronic recalls two types of sterile surgical pins due to fitting issues with patient reference frames during image-guided surgery. Affected units have specific serial numbers and product codes.
MedtronicDec 4, 2024 - Lower riskMedical device
Medtronic Navigation, Inc. recalls StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine
Medtronic recalls StealthStation S8 App versions 1.3.0 and 1.3.2 (Model # 9735762) due to two software anomalies that can cause images to appear flipped or fail to display warnings during spine procedures.
MedtronicAug 22, 2024 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid
Medtronic recalls Stealth S8 Clinical Software versions 1.0.1-1.2.0 for potential missing digits in navigation displays during neurosurgery. Affected units may cause navigation errors.
MedtronicMar 26, 2024 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Medtronic recalls specific percutaneous pins due to potential cross-pin issues that could cause improper fit or removal. Affected units have unique serial numbers and were sold in 2023.
MedtronicNov 28, 2023 - Lower riskMedical device
Medtronic Navigation, Inc. recalls StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation
Medtronic recalls StealthStation S8 software versions 2.0 and 2.0.1 due to potential surgical planning data shifting. Affected units may require software update or replacement to prevent errors in neurosurgery or ENT procedures.
MedtronicSep 27, 2023 - Use cautionMedical device
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Medtronic recalls StealthStation Cranial Software version 3.1.1-3.1.3 for potential inaccuracies during brain surgery, risking tissue injury. Affected units include specific model numbers and software versions.
MedtronicApr 11, 2023 - Use cautionMedical device
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Medtronic recalls specific StealthStation Cranial Software versions used with S7/i7 systems due to inaccurate depth displays during cranial biopsies, potentially causing tissue injury. Affected models include 9735585, 9735586, and 9735587 kits.
MedtronicApr 11, 2023 - Lower riskMedical device
Medtronic Navigation, Inc. recalls AxiEM" Non-Invasive Patient Tracker
Medtronic recalls AxiEM Non-Invasive Patient Tracker devices due to issues verifying navigation instruments during image-guided surgery. Affected units have specific product numbers and lot dates.
Medtr: AxiEMDec 15, 2022 - Lower riskMedical device
Medtronic Navigation, Inc. recalls RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Medtronic recalls pink RadiaLux Lighted Retractors with specific serial numbers due to potential contamination risk leading to post-operative infections. Affected units may need replacement.
MedtronicDec 8, 2022 - UnratedMedical device
Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or
Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 with defective sterile seal that may compromise safety during surgery.
MedtronicOct 14, 2022 - Use cautionMedical device
Medtronic Navigation, Inc. recalls Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial,
Medtronic recalls Stealthstation Cranial Software versions 3.1.1-3.1.2 and 3.1.3 due to potential incorrect biopsy needle positioning during cranial procedures, risking tissue injury and additional surgery.
MedtronicNov 11, 2021 - Use cautionMedical device
Medtronic Navigation, Inc. recalls Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode:
Medtronic recalls Stealth Autoguide Tracker model 28248 due to potential separation causing tissue injury during neurosurgery. Affected units include those in the Stealth Autoguide Basic Instrument Kit.
MedtronicNov 9, 2021 - Lower riskMedical device
Medtronic Navigation, Inc. recalls StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid
Medtronic recalls StealthStation S7 System with Polaris Spectra Camera (PSU 9733437) due to potential navigation inaccuracies of 6mm when using both active and passive trackers simultaneously. No injuries reported.
MedtronicJun 5, 2020 - Stop using nowMedical device
Medtronic Navigation, Inc. recalls Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Medtronic recalls Mazor X Surgical System Positioner Type II (REF: ASM0214-02) due to potential detachment from the operating table, which could fall on a patient causing injury.
MedtronicDec 5, 2019 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
Medtronic recalls biopsy needle kits with potential depth stop issues that could delay surgery. Affected units include specific product numbers and lot numbers.
MedtronicOct 30, 2019 - Lower riskMedical device
Medtronic Navigation, Inc. recalls NavLock Tracker *** Rx Only
Medtronic recalls NavLock Tracker devices (Rx only) with product number 9736061 that may have incorrect assembly, potentially affecting navigation accuracy. Consumers should contact Medtronic for details.
Medtr: NavigationAug 28, 2019 - Use cautionMedical device
Medtronic Navigation, Inc. recalls Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS
Medtronic recalls stereotactic surgery systems and software versions 3.0+ that may cause inaccurate brain implant lead placement during deep brain stimulation procedures. Affected units include specific models with O-arm imaging systems.
MedtronicAug 9, 2019 - Use cautionMedical device
Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS
Medtronic recalls Visualase Cooled Laser Applicator System Tubing Sets with specific product numbers and lot ranges due to potential saline flow disruption from incorrect fittings or adhesive.
MedtronicJul 8, 2019 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915),
Medtronic recalls specific percutaneous pin adapters used in StealthAir Frame Assembly. The adapter may rotate slightly after surgical placement and not return to original position, potentially causing complications.
MedtronicDec 6, 2018 - Use cautionMedical device
Medtronic Navigation, Inc. recalls StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for
Medtronic recalls StealthStation Cranial and Synergy Cranial Depth Gauges with software versions 2.2.0-3.1.0 that may cause biopsy of healthy tissue due to incorrect depth display.
MedtronicSep 26, 2018 - Use cautionMedical device
Medtronic Navigation, Inc. recalls Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Medtronic recalls Visualase software versions 3.1.1-3.2 for potential MRI-guided laser ablation inaccuracies that could spread thermal energy to surrounding tissue.
MedtronicJun 1, 2018 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator
Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 3mm, 10mm, and 15mm tips due to potential low laser energy output from untested fibers, which could cause fiber burnout at lower wattage.
MedtronicMar 23, 2018 - Lower riskMedical device
Medtronic Navigation, Inc. recalls VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;
Medtronic recalls VCLAS 3mm, 10mm, and 15mm laser tips due to potential saline leakage during manufacturing. Affected units include specific part numbers and lots. Consumers should contact Medtronic for details.
MedtronicJul 27, 2017 - Use cautionMedical device
Medtronic Navigation, Inc. recalls Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic
Medtronic recalls spine referencing clamps that may cause spinal injury if damaged during surgery. Learn if your clamps are affected and what to do.
MedtronicJun 29, 2017 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452
Medtronic recalls ENT suction kits that fail instrument verification. These reusable surgical tools may not pass pre-use checks, risking improper function during procedures.
MedtronicJun 29, 2017 - Lower riskMedical device
Medtronic Navigation, Inc. recalls Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um
Medtronic recalls specific VCLAS 15MM TIP models due to potential saline leaks from improper sealing. Affected units may require replacement to prevent complications during medical procedures.
MedtronicJun 7, 2017
Medtronic Navigation, Inc. recall questions
How many recalls has Medtronic Navigation, Inc. had?
44 recalls from Medtronic Navigation, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Medtronic Navigation, Inc. recall?
Medtronic Navigation, Inc. recalls Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly, dated Aug 31, 2026. Every Medtronic Navigation, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Medtronic Navigation, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medtronic Navigation, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.