Recall archive
53 recalls · page 1 of 3
Reported Jun 24, 2026
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
Matched: Brand · Product · Product details — Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
FDA (openFDA device enforcement)
Reported Jul 16, 2025
O-arm O2 Imaging System. Mobile X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
Matched: Brand — A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation…
FDA (openFDA device enforcement)
Reported Jun 12, 2024
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay,…
FDA (openFDA device enforcement)
Reported May 15, 2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point"…
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand — Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA (openFDA device enforcement)
Reported Aug 30, 2023
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Ground cable installed incorrectly.
FDA (openFDA device enforcement)
Reported Jun 14, 2023
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
AxiEM" Non-Invasive Patient Tracker
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to…
FDA (openFDA device enforcement)
Reported Jan 18, 2023
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Due to a defect in the outer pouch sterile seal
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2020
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation…
FDA (openFDA device enforcement)
Reported Jun 17, 2020
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling…
FDA (openFDA device enforcement)
Reported May 27, 2020
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of…
FDA (openFDA device enforcement)
Reported May 13, 2020
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector…
FDA (openFDA device enforcement)
Reported Apr 22, 2020
NavLock Tracker *** Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Product was incorrectly assembled which could affect navigation accuracy of the device.
FDA (openFDA device enforcement)
Reported Jan 8, 2020
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Reason for recall — Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may…
FDA (openFDA device enforcement)
Reported Dec 25, 2019
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and…
FDA (openFDA device enforcement)
Reported Dec 18, 2019
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2019
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Product · Product details — The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly,…
FDA (openFDA device enforcement)
Reported Jan 9, 2019
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Product details — An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of…
FDA (openFDA device enforcement)
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