Medtronic Navigation, Inc.
Louisville, CO
This page shows every FDA and USDA recall linked to Medtronic Navigation, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
92
Total Recalls
2006
First Recall
2023
Most Recent
AxiEM" Non-Invasive Patient Tracker
Jan 30, 2023
· Device
Active
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Jan 12, 2023
· Device
Active
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE
FIBER 10MM TIP product. Used to necrotize...
Nov 17, 2022
· Device
Active
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software.
Syne...
Nov 11, 2021
· Device
Active
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Jun 9, 2020
· Device
Active
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as...
Jun 5, 2020
· Device
Terminated
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthSt...
May 18, 2020
· Device
Terminated
NavLock Tracker *** Rx Only
Apr 10, 2020
· Device
Terminated
Passive Biopsy Needle Kit, UDI: 00643169030121
and 00643169702943
Oct 30, 2019
· Device
Active
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
Oct 30, 2019
· Device
Active
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
Oct 30, 2019
· Device
Active
Visualase Cooled Laser Applicator System Tubing Set kits
Product numbers:
VCLAS 9735559, 3mm tip/1.65mm cathe...
Jul 8, 2019
· Device
Terminated
StealthStation Cranial and Synergy Cranial Depth Gauge:
StealthStation Cranial Optical Pocket Guide - Instruc...
Dec 29, 2018
· Device
Terminated
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 0076300005491...
Dec 6, 2018
· Device
Terminated
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Jun 1, 2018
· Device
Terminated
Visualase Cooled Laser Applicator System (VCLAS) labeled as:
a. Part Number 9735559, Visualase Cooled Laser...
Mar 23, 2018
· Device
Terminated
VCLAS (Visualase Cooled Laser Ablation System)
Part Number: 9735559 Visualase Cooled Laser Applicator System...
Jul 27, 2017
· Device
Terminated
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber...
Jul 3, 2017
· Device
Terminated
Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall
When used with a Medtr...
Jun 29, 2017
· Device
Terminated
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation,...
Jun 29, 2017
· Device
Terminated
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straig...
Jun 29, 2017
· Device
Terminated
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733...
Jun 29, 2017
· Device
Terminated
Spine Referencing Instrumentation, Spinous Process Clamp, Short
When used with a Medtronic StealthStation Navi...
Jun 29, 2017
· Device
Terminated
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation,...
Jun 29, 2017
· Device
Terminated
Spine Referencing Instrumentation, Double Spinous Process Clamp, Short
When used with a Medtronic StealthStati...
Jun 29, 2017
· Device
Terminated
Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall
When used with a Medtronic StealthStatio...
Jun 29, 2017
· Device
Terminated
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation,...
Jun 29, 2017
· Device
Terminated
Spine Referencing Instrumentation, Spinous Process Clamp, Tall
When used with a Medtronic StealthStation Navig...
Jun 29, 2017
· Device
Terminated
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, St...
Jun 29, 2017
· Device
Terminated
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449,...
Jun 29, 2017
· Device
Terminated
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation...
Jun 29, 2017
· Device
Terminated
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Jun 26, 2017
· Device
Terminated
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and...
Jan 11, 2017
· Device
Terminated
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit...
Oct 28, 2016
· Device
Terminated
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit ar...
Oct 28, 2016
· Device
Terminated
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for ship...
Jul 18, 2016
· Device
Terminated
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label...
Jul 18, 2016
· Device
Terminated
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label...
Jul 18, 2016
· Device
Terminated
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label...
Jul 18, 2016
· Device
Terminated
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a l...
Jul 18, 2016
· Device
Terminated
Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for...
Jul 18, 2016
· Device
Terminated
MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a...
Jul 18, 2016
· Device
Terminated
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing...
May 16, 2016
· Device
Terminated
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam ster...
Feb 22, 2016
· Device
Terminated
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N:...
Sep 30, 2015
· Device
Terminated
P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN;
P/N: 97...
Sep 30, 2015
· Device
Terminated
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit.
The image g...
Aug 3, 2015
· Device
Terminated
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit.
The image guided Passi...
Aug 3, 2015
· Device
Terminated
Medtronic Navigated Cannulated Taps
Individual cannulated taps are packaged in a clear plastic tube with prot...
Jun 26, 2015
· Device
Terminated