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Medtronic Navigation, Inc. FDA Recalls

13 recalls on file across devices, 5 of them Class I and 13 still open. Matched by name to MDT.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 ThClass IIDec 4, 2024Due to an increase in complaint that the percutaneous refere	Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference f	Class IIDevices	Dec 4, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation SpinClass IIAug 22, 2024Due to two software anomalies that can occur within a spine	Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orienta	Class IIDevices	Aug 22, 2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid foClass IMar 26, 2024Due to a software issue, there is the potential for a missin	Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distanc	Class IDevices	Mar 26, 2024
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUSClass IINov 28, 2023Their is the potential that the percutaneous pin may have a	Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit in	Class IIDevices	Nov 28, 2023
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUSClass IINov 28, 2023Their is the potential that the percutaneous pin may have a	Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit in	Class IIDevices	Nov 28, 2023
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation CraClass ISep 27, 2023Due to a software anomaly which potentially could result in	Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintend	Class IDevices	Sep 27, 2023
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systemsClass IApr 11, 2023During non-axial/some axial exams, software anomalies occur	During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic di	Class IDevices	Apr 11, 2023
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systemsClass IApr 11, 2023In nonaxial/some axial exams if surgical plan utilized, Targ	In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Nav	Class IDevices	Apr 11, 2023
AxiEM" Non-Invasive Patient TrackerClass IIDec 15, 2022Due to increasing complaint trend for the Non-Invasive Patie	Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indica	Class IIDevices	Dec 15, 2022
RadiaLux Lighted Retractor (Pink), REF: 50-101-1Class IIDec 8, 2022Defect in sterile pouch seal, incomplete seal, of lighted Re	Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, whi	Class IIDevices	Dec 8, 2022
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulClass IIOct 14, 2022Due to a defect in the outer pouch sterile seal	Due to a defect in the outer pouch sterile seal	Class IIDevices	Oct 14, 2022
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy CraniaClass INov 11, 2021Cranial biopsy procedure software can enter a state where th	Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized wit	Class IDevices	Nov 11, 2021
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 973Class IINov 9, 2021A tracker that holds and guides neurosurgical surgical instr	A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure,	Class IIDevices	Nov 9, 2021

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