Medtronic Navigation, Inc.

FDA Regulatory Profile

Summary

Total Recalls
92 (7 Class I)
510(k) Clearances
42
Inspections
11
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1022-2025Class IIMedtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUSDecember 4, 2024
Z-0050-2025Class IIStealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, withAugust 22, 2024
Z-1776-2024Class IStealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStationMarch 26, 2024
Z-0699-2024Class IIMedtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUSNovember 28, 2023
Z-0698-2024Class IIMedtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUSNovember 28, 2023
Z-0188-2024Class IStealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, witSeptember 27, 2023
Z-1630-2023Class IStealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStaApril 11, 2023
Z-1666-2023Class IStealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systemsApril 11, 2023
Z-1039-2023Class IIAxiEM" Non-Invasive Patient TrackerDecember 15, 2022
Z-0953-2023Class IIRadiaLux Lighted Retractor (Pink), REF: 50-101-1December 8, 2022
Z-0244-2023Class IIVisualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used toOctober 14, 2022
Z-0383-2022Class IStealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial SoftwareNovember 11, 2021
Z-0417-2022Class IIStealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic InstrNovember 9, 2021
Z-2707-2020Class IIStealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are iJune 5, 2020
Z-2330-2020Class IIMazor X Surgical System Positioner Type II, REF: ASM0214-02December 5, 2019
Z-0659-2020Class IIBiopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108October 30, 2019
Z-0658-2020Class IIBiopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517October 30, 2019
Z-0657-2020Class IIPassive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943October 30, 2019
Z-1693-2020Class IINavLock Tracker *** Rx OnlyAugust 28, 2019
Z-1995-2020Class IMedtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer withAugust 9, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (973556March 13, 2026
K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationFebruary 12, 2026
K251282StealthStation S8 Spine SoftwareOctober 17, 2025
K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsJune 5, 2025
K250307Visualase V2 MRI-guided Laser Ablation System (9736422)May 29, 2025
K240465O-arm O2 Imaging SystemJune 21, 2024
K231976StealthStation Cranial Software, v3.1.5 (9735585)October 19, 2023
K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4June 10, 2022
K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)January 7, 2022
K212397StealthStation S8 Cranial v2.0December 22, 2021
K211442StealthStation Spinous Process ClampsJuly 8, 2021
K203639StealthStation Cranial Software v1.3.2January 13, 2021
K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)June 26, 2020
K201327NavLock TrackersJune 18, 2020
K201175StealthStation Cranial Software v1.3.0June 3, 2020
K201189Stealthstation S8 Spine Software v1.3.0May 29, 2020
K193579PlasmaBlade X 3.0S LIGHTMarch 24, 2020
K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemNovember 1, 2019
K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1July 31, 2019
K181859Visualase Thermal Therapy SystemMarch 6, 2019