Medtronic Navigation, Inc.

Complete recall history across all FDA and CPSC categories — 91 total recalls

Medtronic Navigation, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (91)

FDA medical device enforcement actions by Medtronic Navigation, Inc.. Showing most recent 50.

Date Product Reason Class
Dec 4, 2024 Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150M... Due to an increase in complaint that the percutaneous reference pin would not... Class II
Aug 22, 2024 StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stea... Due to two software anomalies that can occur within a spine procedure. Two i... Class II
Mar 26, 2024 Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Use... Due to a software issue, there is the potential for a missing digit, letter, ... Class I
Nov 28, 2023 Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that ma... Class II
Nov 28, 2023 Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that ma... Class II
Sep 27, 2023 StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Ste... Due to a software anomaly which potentially could result in the surgical plan... Class I
Apr 11, 2023 StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/... In nonaxial/some axial exams if surgical plan utilized, Target Guidance selec... Class I
Apr 11, 2023 StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit... During non-axial/some axial exams, software anomalies occur during procedures... Class I
Dec 15, 2022 AxiEM" Non-Invasive Patient Tracker Due to increasing complaint trend for the Non-Invasive Patient Tracker system... Class II
Dec 8, 2022 RadiaLux Lighted Retractor (Pink), REF: 50-101-1 Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increas... Class II
Oct 14, 2022 Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10M... Due to a defect in the outer pouch sterile seal Class II
Nov 11, 2021 Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or ... Cranial biopsy procedure software can enter a state where the biopsy depth ga... Class I
Nov 9, 2021 Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealt... A tracker that holds and guides neurosurgical surgical instruments may be sub... Class II
Jun 5, 2020 StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437... There is a potential for specific camera units to be affected by a characteri... Class II
Dec 5, 2019 Mazor X Surgical System Positioner Type II, REF: ASM0214-02 There is a potential for the surgical system to detach from the operational r... Class II
Oct 30, 2019 Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 The firm has become aware that due to a manufacturing issue impacting the bio... Class II
Oct 30, 2019 Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 The firm has become aware that due to a manufacturing issue impacting the bio... Class II
Oct 30, 2019 Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 The firm has become aware that due to a manufacturing issue impacting the bio... Class II
Aug 28, 2019 NavLock Tracker *** Rx Only Product was incorrectly assembled which could affect navigation accuracy of t... Class II
Aug 9, 2019 Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... Entry point and lead placement inaccuracies during deep brain stimulation lea... Class I
Jul 8, 2019 Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: ... The firm received complaints on the saline tubing of Visualase Cooled Laser A... Class II
Dec 6, 2018 Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and RE... Under certain circumstances, the percutaneous pin adapter used with the Steal... Class II
Sep 26, 2018 StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cra... An incorrect display of the Biopsy Depth Gauge graphical representation in th... Class I
Jun 1, 2018 Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1... Inaccuracy of MR thermometry during MRI-guided laser ablation procedures usin... Class II
Mar 23, 2018 Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM... Class II
Jul 27, 2017 VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visuala... The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for s... Class II
Jun 29, 2017 Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is perform... Class II
Jun 29, 2017 Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t... The instruments are not able to pass instrument verification which is perform... Class II
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Short When used wi... Potential for Spinal Clamps to be damaged when opened beyond intended limits,... Class II
Jun 29, 2017 Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes... The instruments are not able to pass instrument verification which is perform... Class II
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used wit... Potential for Spinal Clamps to be damaged when opened beyond intended limits,... Class II
Jun 29, 2017 Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This k... The instruments are not able to pass instrument verification which is perform... Class II
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When u... Potential for Spinal Clamps to be damaged when opened beyond intended limits,... Class II
Jun 29, 2017 Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on ... The instruments are not able to pass instrument verification which is perform... Class II
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When ... Potential for Spinal Clamps to be damaged when opened beyond intended limits,... Class II
Jun 29, 2017 Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is perform... Class II
Jun 29, 2017 Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Shor... Potential for Spinal Clamps to be damaged when opened beyond intended limits,... Class II
Jun 29, 2017 Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, R... The instruments are not able to pass instrument verification which is perform... Class II
Jun 29, 2017 Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit incl... The instruments are not able to pass instrument verification which is perform... Class II
Jun 7, 2017 Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9... Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as T... Class II
May 10, 2017 Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Software issue related to the StealthStation S7 system and the Synergy Spine ... Class II
Dec 12, 2016 AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG... Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM T... Class II
Sep 1, 2016 Visualase Body Accessory Kit PN 020-3000. The individual components within th... Medtronic Navigation, Inc. announces a voluntary field action for the Visuala... Class II
Sep 1, 2016 Visualase Visualization Stylets PN 020-2301. The individual components within... Medtronic Navigation, Inc. announces a voluntary field action for the Visuala... Class II
Jul 18, 2016 MACH Cranial Treon. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtron... Class II
Jul 18, 2016 MACH AxiEM Cranial Treon. The software application is sent in CD format with ... Medtronic Navigation, Inc. announces a voluntary field action for the Medtron... Class II
Jul 18, 2016 Synergy Spine. The software application is sent in CD format with an IFU, wra... Medtronic Navigation, Inc. announces a voluntary field action for the Medtron... Class II
Jul 18, 2016 Fusion ENT Application. The software application is sent in CD format with an... Medtronic Navigation, Inc. announces a voluntary field action for the Medtron... Class II
Jul 18, 2016 Synergy Cranial S7. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtron... Class II
Jul 18, 2016 FrameLink. The software application is sent in CD format with an IFU, wrapped... Medtronic Navigation, Inc. announces a voluntary field action for the Medtron... Class II

View all 91 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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