Medtronic Navigation, Inc.: 55 recalls on record

Recalls filed with 1 agency: FDA (55).

First recall on record: June 27, 2012. Most recent: February 5, 2025.

Risk classification: Class I: 2 · Class II: 53

Most recent recalls

DateAgencyProduct
February 5, 2025FDAMedtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE P…Z-1022-2025
October 16, 2024FDAStealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation S…Z-0050-2025
May 15, 2024FDAStealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the Ste…Z-1776-2024
January 17, 2024FDAMedtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUSZ-0699-2024
January 17, 2024FDAMedtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUSZ-0698-2024
August 5, 2020FDAStealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product U…Z-2707-2020
June 17, 2020FDAMazor X Surgical System Positioner Type II, REF: ASM0214-02Z-2330-2020
May 13, 2020FDAVisualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 97355…Z-1905-2020
December 18, 2019FDABiopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517Z-0658-2020
January 9, 2019FDAStealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical…Z-0552-2019
September 27, 2017FDASpine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtroni…Z-3139-2017
September 27, 2017FDASpine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall …Z-3143-2017
September 27, 2017FDASpine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a M…Z-3141-2017
September 27, 2017FDASpine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a …Z-3142-2017
August 30, 2017FDAMedtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is M…Z-3054-2017
August 30, 2017FDAMedtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908…Z-3058-2017
August 30, 2017FDAMedtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is…Z-3053-2017
August 30, 2017FDAMedtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit…Z-3055-2017
August 30, 2017FDAMedtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains …Z-3057-2017
August 2, 2017FDAMedtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) …Z-2755-2017
July 26, 2017FDAInstall CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.Z-2746-2017
January 18, 2017FDAAxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed…Z-1007-2017
November 9, 2016FDAVisualase Body Accessory Kit PN 020-3000. The individual components within the Visualase …Z-0323-2017
August 10, 2016FDAS7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in …Z-2315-2016
November 26, 2014FDAINST 9731132 KIT CR REF FRAME DRIVER 5PKZ-1585-2014

Questions about this company

How many recalls does Medtronic Navigation, Inc. have?
Recalert has 55 U.S. recalls on record for Medtronic Navigation, Inc., published between June 27, 2012 and February 5, 2025.
What was the most recent Medtronic Navigation, Inc. recall?
FDA recall Z-1022-2025, published February 5, 2025: Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and re…
Which agencies have handled Medtronic Navigation, Inc. recalls?
Medtronic Navigation, Inc. appears as the recalling firm in recalls from: FDA (55).

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