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Medtronic Navigation Recalls
92 recalls on record · June 27, 2012 to February 5, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2015Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174,
Hazard: Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls TUMOR RESECTION KIT 9733608 SKULL MOUNT
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls TUMOR RESECTION KIT 9733607 NON-INVASIVE
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls TUMOR RES. PACK 9733553 AxiEM S.M.
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls TRAJ GUIDE KIT, 9733066, BIOPSY, INT
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls SPHERES 8801075 5/TRAY 12PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls SPHERES 8801071 1/TRAY 12PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls SHUNT KIT 9733605 NON-INVASIVE
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls PIN, 9733236, 150MM, STERILE, PERC REF
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls PIN, 9733235, 100MM, STERILE, PERC REF
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls PATIENT TRACKER 9733534XOM ENT 1PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls PACK 9731975 TUMOR RESECTION AXIEM CR
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls MOUSE 9732721 STERILE O-ARM 10PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls KIT, 9731427, THORACIC TACTILE PROBES
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls INSTRUMENT TRACKER 9733533XOM ENT 1PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls INST 9731132 KIT CR REF FRAME DRIVER 5PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls ENT PRGM 9734636 ADD FUSION NAV AxiEM
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls DRAPE 9732722 TUBE STERILE O-ARM 20PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls DISP 9730951 STRL SPHERE, 5PK INSERT
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls DISP 9730950 STRL SPHERE, 1 PK INSERT
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls BIT 9733516 2.9mm DRILL STERILE
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls BIOPSY NEEDLE KIT, 9733068, PASSIVE
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
November 26, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls BAG 9732315 MOUSE STERILE 15 PK
Hazard: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
March 12, 2014Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System
Hazard: Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)
August 21, 2013Medical DevicesFDA
Medtronic Navigation, Inc. recalls StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical traje
Hazard: Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
March 20, 2013Medical DevicesFDA
Medtronic Navigation, Inc. recalls Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Hazard: Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
December 5, 2012Medical DevicesFDA
Medtronic Navigation, Inc. recalls The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated
Hazard: Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.