VisualaseRecalls & reported problems across all models
Medtronic Navigation, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Visualase model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 625
- Deaths reported
- 3
- Injuries reported
- 158
- Recalls
- 3
We found 25 models of Visualase by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 625 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2016 and Sep 30, 2026 — classified as 3 deaths, 158 injuries, 464 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (198 reports).
3 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Visualase recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 14, 2022Open, Classified
Due to a defect in the outer pouch sterile seal
Z-0244-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jun 1, 2018Terminated
Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.
Z-3251-2018 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Mar 23, 2018Terminated
Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the potential for low laser energy output from fiber or fiber burnout at lower wattage.
Z-2501-2018 · Root cause: Equipment maintenance · names 7 of these models · Recall details · FDA record ↗
Most reported Visualase problems
Device problems
- Mechanical Problem198
- Adverse Event Without Identified Device or Use Problem130
- Incorrect, Inadequate or Imprecise Result or Readings56
- No Device Output37
- Infusion or Flow Problem34
- Device Operates Differently Than Expected29
- Insufficient Heating29
- Thermal Decomposition of Device27
Patient problems
- No Clinical Signs, Symptoms or Conditions283
- No Known Impact Or Consequence To Patient119
- No Consequences Or Impact To Patient42
- Visual Impairment41
- Iatrogenic Source36
- No Patient Involvement34
- Intracranial Hemorrhage15
- Headache12
Visualase models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Visualase 9735542Powered laser surgical instrument1 recall2 deaths311 reports
- Visualase 9735542Powered laser surgical instrument1 recall87 reports
- Visualase 9735560Neurosurgical laser with MR thermography1 recall59 reports
- Visualase 9735560Neurosurgical laser with MR thermography1 recall4 reports
- Visualase 9735560Neurosurgical laser with MR thermography1 recall3 reports
- Visualase 9735559Neurosurgical laser with MR thermography1 recall3 reports
- Visualase 9735561Powered laser surgical instrument1 recall1 report
- Visualase 9735559Neurosurgical laser with MR thermography1 recall0 reports
- Visualase 9735561Powered laser surgical instrument1 recall0 reports
- Visualase 9735561Powered laser surgical instrument1 recall0 reports
- Visualase 9735560Neurosurgical laser with MR thermography44 reports
- Visualase 9735542Powered laser surgical instrument20 reports
- Visualase 9735571INSTRUMENT, MANUAL, SURGICAL, GENERAL USE19 reports
- Visualase 002-1100Powered laser surgical instrument1 death15 reports
- Visualase 9735542Neurosurgical laser with MR thermography15 reports
- Visualase 9735559Neurosurgical laser with MR thermography15 reports
- Visualase 9735559Neurosurgical laser with MR thermography10 reports
- Visualase 9735552Powered laser surgical instrument4 reports
- Visualase 9735571INSTRUMENT, MANUAL, SURGICAL, GENERAL USE4 reports
- Visualase 9735561Powered laser surgical instrument3 reports
- Visualase 9735561Neurosurgical laser with MR thermography3 reports
- VISUALASE 9735542Neurosurgical laser with MR thermography2 reports
- Visualase 9735570Cannula and trocar, suprapubic, non-disposable1 report
- Visualase 9735571INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 report
- Visualase 9735560Neurosurgical laser with MR thermography1 report
Recent Visualase adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash
Medtronic received information regarding a thermal therapy system being used in a Hemispherectomy procedure. It was reported that the catheter started to leak. There was a two and a half hour delay due to troubleshooting and replacing the catheter. There was no impact on the patient's outcome.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948622 ↗MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916378 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S POST SCANS REVEALED A BLEED. THERE WAS NO DELAY TO THE PROCEDURE. THE PATIENT HAS HAD NO IMPACTS SINCE THE PROCEDURE.
Patient problems: Intracranial Hemorrhage
MAUDE report 25206288 ↗MalfunctionMay 7, 2026Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) STRUGGLED TO REMOVE THE BONE ANCHOR. THE BONE ANCHOR SNAPPED. THE HCP HAD TO MAKE A SMALL INCISION TO USE AN INSTRUMENT IN ORDER FOR THE BONE ANCHOR TO BE REMOVED. THE SITE STATED THAT AFTER THE PROCEDURE, THE TITANIUM BONE ANCHOR WAS INTENDED TO BE UNSCREWED AND REMOVED EASILY BUT THE WHITE PLASTIC PART WAS SNAPPED DURING REMOVAL. THE HCP HAD TO MAKE A SMALL INCISION AND USED ADDITIONAL INSTRUMENT TO REMOVE THE TITANIUM BONE ANCHOR. THE DEVICE CAME OUT INTACT AS INSPECTED BY THE HCP. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116856 ↗MalfunctionApr 23, 2026Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A NEWLY OPENED COOLING CATHETER IN A 10 MM KIT WAS KINKED. THE CUSTOMER WAS ABLE TO OPEN A NEW ONE AND MOVE FORWARD WITH THEIR CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974792 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT A PATIENT MAY HAVE SUSTAINED NERVE DAMAGE AS A RESULT OF AN ABLATION CASE PERFORMED INVOLVING THIS SYSTEM. SPECIFICALLY AFTER THE PROCEDURE THE PATIENT NOW HAS A DEFICIT TO CRANIAL NERVES 7 AND 8, CAN'T MOVE HALF OF THEIR FACE AND HAS HEARING LOSS IN ONE EAR. PATIENT PRESENT, NO DELAY. EVERYTHING REPORTEDLY LOOKED GOOD AND NORMAL DURING ABLATION.
Patient problems: Facial Paralysis; Nerve Damage; No Clinical Signs, Symptoms or Conditions; Paralysis; Partial Hearing Loss; Unspecified Nervous System Problem
MAUDE report 24887248 ↗MalfunctionApr 15, 2026Leak/Splash
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED AFTER A CASE THEY NOTICED AN UNUSUAL AMOUNT OF LIQUID, POSSIBLY SALINE FROM THE COOLING CATHETER, PRESENT AROUND THE PATIENT'S HEAD. THERE WERE NO ISSUES DURING THE PROCEDURE; NO INDICATION OF A POSSIBLE LEAK PRIOR TO THE PROCEDURE. THERE WAS NO DELAY. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886967 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BRAIN HEMORRHAGE WHILE SETTING UP FOR A NEURO ABLATION CASE. NO ABLATION WAS PERFORMED; THE ISSUE OCCURRED AFTER PLACING TWO CATHETERS WITH A ROBOT AND WAS NOTICED AFTER INITIAL MAGNETIC RESONANCE IMAGING (MRI) SCANS. THE SURGEON OPTED TO ABORT THE PROCEDURE.
Patient problems: Intracranial Hemorrhage
MAUDE report 24818196 ↗MalfunctionMar 23, 2026Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CYLINDER THAT CONNECTS TO THE RETURN BAG WAS MOUNTED UPSIDE DOWN, SO THE HOLDER DID NOT WORK WITHOUT KINKING THE TUBE TO THE BAG CONNECTOR. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24665040 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BRAIN BLEED, UNRELATED TO MEDTRONIC EQUIPMENT. A THIRD PARTY ROBOTIC SURGICAL ASSISTANCE ROBOT WAS USED FOR NAVIGATION. THE BLEED WAS NOT IN THE AREA OF ABLATION. THE CATHETERS PERFORMED AS EXPECTED. ABLATION WAS SUCCESSFULLY PERFORMED AND WERE INSPECTED AFTER THE PROCEDURE. BOTH CATHETERS USED WERE INTACT BEFORE AND AFTER THE PROCEDURE. PER THE SURGEON, NO OTHER SURGICAL INTERVENTION WAS NEEDED WHEN THE PATIENT WAS EVALUATED AFTER THE PROCEDURE. THE PATIENT WAS TO BE MONITORED. THERE WAS A DELAY FOR EVALUATION OF THE PATIENT WHICH WAS 20 MINUTES. THE PATIENT WAS STABLE THE FOLLOWING DAY.
Patient problems: Intracranial Hemorrhage
MAUDE report 24471138 ↗MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT TMAP WAS NOT TRANSFERRING. DURING THE CASE THE SYSTEM WOULD NOT TRANSFER TMAP IMAGES PROPERLY INTO THE SESSION. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO RE-LOAD THE IMAGES, THE MANUFACTURER REPRESENTATIVE (REP) REBOOTED THE SYSTEM AND THE ISSUE SEEMED TO RESOLVE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344702 ↗MalfunctionFeb 11, 2026Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S COOLING FLUID PUMP MALFUNCTIONED IN A CASE. THE PROCEDURE WAS APPROXIMATELY 80% COMPLETE, AT WHICH TIME THE PUMP STOPPED MOVING AND BEGAN MAKING A "SQUEALING" NOISE AS IF A GEAR WAS JAMMED INSIDE. THE MANUFACTURER REPRESENTATIVE (REP) TRIED REVERSING DIRECTIONS AS WELL AS DIFFERENT POWER OUTLETS, BUT THE ISSUE PERSISTED. THE REP WAS ABLE TO MANUALLY MOVE A BEARING IN THE PUMP AND GET IT WORKING AGAIN FOR APPROXIMATELY 30 SECONDS, BUT THEN IT STOPPED MOVING AGAIN. THE REP WAS UNABLE TO GET IT WORKING AT THAT POINT. THE SURGEON THEN OPTED TO ABANDON FURTHER USE OF THE SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316272 ↗MalfunctionJan 29, 2026No Device Output; Failure to Read Input Signal
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE LOCAL REPRESENTATIVE (LASC) CALLED ON BEHALF OF THE SITE TO REPORT THAT WHILE IN A CASE, THE TIO SCREEN OF THE SYSTEM BEGAN DISPLAYING " POWER BUTTON LOCK" AND THE SURGEONS COULD NO LONGER USE THE SCREEN. BASED ON THE DESCRIPTION, TECHNICAL SERVICES (TS) BELIEVED THAT THIS WAS THE V1 MONITOR TOUCH SCREEN ISSUE THAT OCCURRED WHEN THE POWER BUTTON ON THE MONITOR WAS PRESSED. THE WHOLE SCREEN WAS BLACK WITH THE MESSAGE, NO VIDEO AT ALL. THE LASC TEAM TRIED REBOOTING AND RESEATING ALL CABLES INTO THE MONITOR WITH NO CHANGE. ANOTHER LOCAL REPRESENTATIVE (REP) CALLED TO REPORT THAT SHE MOVED THE DISPLAY PORT (DP) FROM THE LOWER SCREEN TO THE UPPER MONITOR, AND THE VIDEO WAS RESTORED. THE REP CONFIRMED THAT SHE ONLY MOVED THE MONITOR DP CABLE FROM THE LOWER TO THE UPPER MONITOR, BUT NEVER SWAPPED CONNECTIONS ON THE COMPUTER SIDE AS WELL. IT WAS NOTED THAT POTENTIALLY, THIS COULD BE A COMPUTER ISSUE, BUT HAS YET TO BE TESTED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. PATIENT IMPACT INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209274 ↗MalfunctionJan 23, 2026Thermal Decomposition of Device; Leak/Splash
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A NEURO ABLATION PROCEDURE.. IT WAS REPORTED THAT ONE OF THE CATHETERS HAD A CHARRED TIP. THIS WAS SEEN UPON REMOVING THE CATHETER. THE LOCAL REPRESENTATIVE (REP) TESTED WITH SALINE INSIDE OF THE CATHETER TO SEE IF THERE WAS A LEAK, AND THERE WAS FOUND TO BE A VERY SMALL LEAK AT THE TIP OF THE CATHETER. NO HARM TO THE PATIENT WAS FOUND AND THE SURGEON WAS AWARE. THERE WAS NO DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164295 ↗MalfunctionJan 2, 2026Erratic or Intermittent Display; Connection Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE THERMAL ABLATION SYSTEM DISCONNECTED FROM THE MRI DURING SURGERY ON (B)(6) 2025. A MANUFACTURER REPRESENTATIVE (REP) HAD DONE PRE SURGERY CHECKS AND FOUND THAT WHILE TESTING THERMAL MAPS (TMAPS) ON A PHANTOM KIT, THE SCANNER DISCONNECTED AFTER RUNNING FOR A FEW MINUTES. THE REP WAS ABLE TO REPLICATE THIS BUT WITH VARIOUS TIME BEFORE IT DISCONNECTED. REP CHECKED TMAP PARAMETERS, LOWERED SCANNER REPETITION TIME TO DECREASE SCAN TIME, AND CHECKED CONNECTIONS WITH NO SUCCESS. MRI SCANNER APPLICATION WAS REBOOTED, ACCESS-I ROUTER REBOOTED, ETHERNET CABLE SWAPPED, PULLED OVER ANOTHER 2 PLANE TMAP FROM A FOLDER OF PROTOCOLS FROM INSTALL, CHECKED PARAMETERS AND USED IT. REP WAS THEN ABLE TO RUN A 8-10+ MINUTE TMAP SESSIONS WITH NO ABRUPT DISCONNECTIONS. REP WAS ABLE TO USE THERMAL ABLATION SYSTEM FOR TWO CASES WITHOUT ISSUE. ON THE THIRD CASE, THEY HAD COMPLETED MULTIPLE ABLATIONS WITH PULLBACKS BEFORE THE SYSTEM DISCONNECTED FROM THE SCANNER ON THE LAST ABLATION BEFORE CASE COMPLETION. REP RAN A NEW SESSION, BUT SCANNER DISCONNECTED AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943669 ↗
Other Medtronic Navigation, Inc. products
- O-ARM17 models · 9,235 reports · 5 recalls
- StealthStation S8 Platform14 models · 8,402 reports
- Stealthstation S711 models · 5,756 reports
- StealthStation S86 models · 2,235 reports
- Fusion ENT Image Guidance System5 models · 2,033 reports
- NavLock9 models · 134 reports · 1 recall
- AxiEM12 models · 62 reports · 2 recalls
- StealthStation Cranial13 models · 2 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page