Every recall we track for Medtronic Navigation, Inc. — 40 in all — plus the complaints and injury reports the public filed about them.
Medtronic recalls two types of sterile surgical pins due to fitting issues with patient reference frames during image-guided surgery. Affected units have specific serial numbers and product codes.
Medtronic recalls StealthStation S8 App versions 1.3.0 and 1.3.2 (Model # 9735762) due to two software anomalies that can cause images to appear flipped or fail to display warnings during spine procedures.
Medtronic recalls Stealth S8 Clinical Software versions 1.0.1-1.2.0 for potential missing digits in navigation displays during neurosurgery. Affected units may cause navigation errors.
Medtronic recalls specific percutaneous pins due to potential cross-pin issues that may prevent proper fitting into tap caps or cause difficulty removing.
Medtronic recalls specific percutaneous pins due to potential cross-pin issues that could cause improper fit or removal. Affected units have unique serial numbers and were sold in 2023.
Medtronic recalls StealthStation S8 software versions 2.0 and 2.0.1 due to potential surgical planning data shifting. Affected units may require software update or replacement to prevent errors in neurosurgery or ENT procedures.
Medtronic recalls StealthStation Cranial Software version 3.1.1-3.1.3 for potential inaccuracies during brain surgery, risking tissue injury. Affected units include specific model numbers and software versions.
Medtronic recalls specific StealthStation Cranial Software versions used with S7/i7 systems due to inaccurate depth displays during cranial biopsies, potentially causing tissue injury. Affected models include 9735585, 9735586, and 9735587 kits.
Medtronic recalls AxiEM Non-Invasive Patient Tracker devices due to issues verifying navigation instruments during image-guided surgery. Affected units have specific product numbers and lot dates.
Medtronic recalls pink RadiaLux Lighted Retractors with specific serial numbers due to potential contamination risk leading to post-operative infections. Affected units may need replacement.
Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 with defective sterile seal that may compromise safety during surgery.
Medtronic recalls Stealthstation Cranial Software versions 3.1.1-3.1.2 and 3.1.3 due to potential incorrect biopsy needle positioning during cranial procedures, risking tissue injury and additional surgery.
Medtronic recalls Stealth Autoguide Tracker model 28248 due to potential separation causing tissue injury during neurosurgery. Affected units include those in the Stealth Autoguide Basic Instrument Kit.
Medtronic recalls StealthStation S7 System with Polaris Spectra Camera (PSU 9733437) due to potential navigation inaccuracies of 6mm when using both active and passive trackers simultaneously. No injuries reported.
Medtronic recalls Mazor X Surgical System Positioner Type II (REF: ASM0214-02) due to potential detachment from the operating table, which could fall on a patient causing injury.
Medtronic recalls specific Passive Biopsy Needle Kits with UDI numbers 00643169030121 and 00643169702943 due to potential needle depth stop issues that could delay surgery. Affected units include certain lot numbers.
Medtronic recalls biopsy needle kits with potential depth stop issues that could delay surgery. Affected units include specific product numbers and lot numbers.
Medtronic recalls biopsy needle kits with potential depth stop issues that could delay surgery. Affected units include specific product numbers and lot numbers.
Medtronic recalls NavLock Tracker devices (Rx only) with product number 9736061 that may have incorrect assembly, potentially affecting navigation accuracy. Consumers should contact Medtronic for details.
Medtronic recalls stereotactic surgery systems and software versions 3.0+ that may cause inaccurate brain implant lead placement during deep brain stimulation procedures. Affected units include specific models with O-arm imaging systems.
Medtronic recalls Visualase Cooled Laser Applicator System Tubing Sets with specific product numbers and lot ranges due to potential saline flow disruption from incorrect fittings or adhesive.
Medtronic recalls specific percutaneous pin adapters used in StealthAir Frame Assembly. The adapter may rotate slightly after surgical placement and not return to original position, potentially causing complications.
Medtronic recalls StealthStation Cranial and Synergy Cranial Depth Gauges with software versions 2.2.0-3.1.0 that may cause biopsy of healthy tissue due to incorrect depth display.
Medtronic recalls Visualase software versions 3.1.1-3.2 for potential MRI-guided laser ablation inaccuracies that could spread thermal energy to surrounding tissue.
Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 3mm, 10mm, and 15mm tips due to potential low laser energy output from untested fibers, which could cause fiber burnout at lower wattage.
