Visualase 9735542 (UDI 00763000402082)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00763000402082), received between Oct 8, 2021 and Oct 18, 2024 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K181859); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ONLY WHEN REMOVING THE FIBER THE BURN WAS NOTICED. SINCE THE INSERTION METHOD IS CLEARPOINT THE HEALTH CARE PROFESSIONAL (HCP) DID NOT WANT TO RISK DESTROYING THE STERILE ENVIRONMENT LEANING IN AND PULLING OUT THE FIBER TO CHECK (IF NOT NEEDED). THEY ONLY CHECKED WITH THE LASER IN STANDBY MODE IF THEY COULD SEE A RED LIGHT COMING OUT FROM A POSSIBLE BREAKAGE AT THE CLEARPOINT TOWER/BEFORE THE TOWER. SINCE THEY STILL GOT A HEATING EFFECT ONLY AFTER A FEW ABLATIONS THEY REALIZED IT MUST BE A BURNED FIBER. AFTER LOG9 THE TABLE WAS MOVED TO THE BACK OF THE SCANNER AND THE LASERFIBER WAS REMOVED FROM THE CATHETER. AT THIS TIME IT WAS CONFIRMED THAT THE FIBER WAS BURNED. THE HCP DECIDED THOUGH TO LEAVE THE OLD CATHETER IN PLACE AND ONLY PUT IN A NEW FIBER (LOG10-12). AFTER LOG12 THE PATIENT WAS MOVED OUT TO THE BACK AGAIN AND THE CATHETER/NEW FIBER WAS REMOVED. A NEW CATHETER WAS THEN INTRODUCED WITH THAT FIBER INTO TRAJECTORY2. THE REMOVED CATHETER WHICH HOSTED THE BURNED FIBER BEFORE DID NOT SHOW ANY LEAKAGE (CHECKED WITH RUNNING SALINE FLOW). THERE WAS NO OBVIOUS CHARRING VISIBLE BUT THERE MIGHT HAVE BEEN SOME CHARRED SPOTS INSIDE THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481617 ↗
• MalfunctionJun 21, 2024Failure to Read Input Signal; 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 MANUFACTURER REPRESENTATIVE (REP) NOTICED THAT THE THERMAL THERAPY SYSTEM SOFTWARE¿S ACCESS-I CONNECTION CONNECT BUTTON WAS GRAYED OUT AND NON-FUNCTIONAL. UPON CLOSING SESSION IN THE SOFTWARE, NEW SESSIONS COULD NOT BE OPENED, NOR SYSCONFIG PROFILES COULD BE CHOSEN WITHOUT GETTING SESSION ERRORS THAT IT WAS BUSY. THE SYSTEM HAD BEEN CHECKED THAT MORNING PER NORMAL PRE CASE CHECKS. THE LASER ABLATION CLINICAL SPECIALIST HAD REPORTEDLY HAD TO USE THE MAINTENANCE TOOL TO UNLOCK AND CLEAR FLAGS A COUPLE OF TIMES TO GET THE SYSCONFIG PROFILE TO LOAD AND LET HIM OPEN A SESSION. FOLLOWING THE MORNING CONNECTION CHECKS PERFORMED AS NORMAL, A SESSION OPENED, ACCESS-I CONNECTED, AND ALL CHECKS PASSED. UPON ARRIVING TO MAGNETIC RESONANCE IMAGING (MRI) WITH A PATIENT FOUR HOURS LATER, IT WAS DISCOVERED IN THIS NON-FUNCTIONAL STATE SO TROUBLESHOOTING BEGAN WHILE MRI IMAGING WAS GOING ON. UPON REBOOT, IT WAS NOTED THAT THERE WAS SUDDENLY 9.3GB OF SYSTEM PARTITION MEMORY AVAILABLE AT 48% USAGE. THE SYSTEM WAS NOTED TO BE ON SOFTWARE APPLICATION 3.3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582234 ↗
• InjuryApr 25, 2024Malposition of Device; Malposition of Device

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CATHETER WAS MISPLACED AT THE FIRST INSERTION WITH A COMPETITOR SYSTEM. THE TRAJECTORY WAS PLANNED IN THE COMPETITOR SYSTEM SOFTWARE. IT WAS INDICATED THAT IT WAS DIFFICULT TO ANSWER AS TO WHY THE TRAJECTORY DEVIATED FROM THE PLAN. IT WAS MOST LIKELY THAT THE COMPETITOR SYSTEM HOLDER MOVED DURING THE DRILLING, OR THE HEAD POSITION MOVED WITH THE HEAD CLAMP. THE CATHETER WAS PLACED INACCURATELY. THE TARGET ERROR WAS TOO HIGH TO START THE ABLATION PROCEDURE. NEW TRAJECTORY WAS CHOSEN AT THE OPPOSITE HEMISPHERE. ACCORDING TO THE TEAM POST-SURGERY, THE PATIENT HAD NO ISSUES AFTER WAKING UP FROM ANESTHESIA. A SECOND UNNECESSARY INCISION AND DRILL HOLE IN THE BONE WAS DONE AT THE OTHER HEMISPHERE (INCISION LEFT AND RIGHT.) THERE WAS A REPORTED DELAY TO THE PROCEDURE OF MORE 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 19185561 ↗
• MalfunctionApr 19, 2024Break; Mechanical Problem; Break; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT). IT WAS REPORTED THAT  THERE WAS A LEAK IN THE TUBING. THERE WAS A PIN-SIZED LEAK IN THE DUO PUMP TUBING LINE THAT WAS FOUND AFTER THE CASE CONCLUDED. SALINE WAS FLOWING THROUGH LINE DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143027 ↗
• MalfunctionMar 20, 2024Energy Output Problem; Energy Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CLINICALLY USED LASER DIFFUSING FIBER WAS INSERTED INTO "SMA" CONNECTION AND TONE WAS RECEIVED ON OPEN/CLOSE OF SESSION. AFTER ALL IMAGING SETUP WITH MRI, THE LASER WAS PUT IN STANDBY AND THEN ENGAGED TO TEST DOSE AT 30%. NO TONE WAS GIVEN NOR WAS IMAGING PICKING UP ON ANY CHANGES IN TEMPERATURE, ALTHOUGH THE LASER ON THE TIMER WAS COUNTING DOWN. TROUBLESHOOTING WAS PERFORMED. THE SITE TRIED RESEATING THE LASER GENERATOR SERIAL CONNECTION, TERMINATOR, AND LASER CONTROL INTERFACE USB CONNECTIONS, AS WELL AS RESEATING LASER DIFFUSING FIBER "SMA" CONNECTION WITH NO SUCCESS "AT LEAST" TWICE. THEY NEVER RECEIVED ANY MESSAGES IN THE LASER MODULATION SOFTWARE WINDOW, INDICATING THE LASER CONTROL INTERFACE WAS NOT DETECTED. THEY THEN PLUGGED IN THE FOOT PEDAL AND DISCONNECTED THE SERIAL CONNECTION TO THE LASER CONTROL INTERFACE TO FIRE MANUALLY AT 5 WATTS ON THE GENERATOR AND GOT NO TONE / NO LASER ENERGY, EVEN AFTER RESEATING COMPONENTS AND POWER CYCLING GENERATOR. THEY THEN TURNED OFF SYSTEM, RESEATED ALL RELEVANT CONNECTIONS, AND BOOTED B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947247 ↗
• MalfunctionAug 2, 2023Mechanical Problem; Device Damaged Prior to Use; Mechanical Problem; Device Damaged Prior to Use

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ON ARRIVAL TO THE SITE, THE LASER FIBERS FOR THIS SYSTEM WERE EITHER BENT OR COMPLETELY BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441499 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ADVERSE EVENTS DOCUMENTED IN THIS ARTICLE ARE NOT RELATED TO MEDTRONIC DEVICES.

  Patient problems: Hydrocephalus; Paresis

  MAUDE report 17352077 ↗
• InjuryJan 24, 2023Image Display Error/Artifact; Excessive Heating; Image Display Error/Artifact; Excessive Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT DURING A CASE THEY HAD TO ABORT USE OF THE SYSTEM DUE TO IMAGE ANOMALIES. THE PROCEDURE WAS DONE IN 2 PHASES BUT WAS ULTIMATELY ABORTED. THE FIRST SET OF ABLATIONS ON 4 TRAJECTORIES UTILIZING 2 LASERS AND MOVING THEM LEVEL BY LEVEL WENT AS USUAL WITH NO REPORTED IMAGING ISSUES OR ANOMALIES. PATIENT WAS REMOVED FROM SCANNER AND THE USED STERILE COOLING CATHETERS AND LASERS WERE REMOVED AND KEPT STERILE FOR USE IN SECOND PHASE OF PROCEDURE. A NEW STERILE TUBING WAS OPENED AND USED. TYPICAL IMAGING WAS DONE TO SETUP THE AXIAL MONITORING PLANES IN TEMPERATURE MAP (TMAP) SEQUENCE PER USUAL PROCESS BUT SIGNIFICANT FLUCTUATIONS IN TEMPERATURE BEGAN FLOODING THE TMAP IMAGING ON THE SYSTEM CONSOLE EVEN AFTER SETTING PHASE REFERENCE MULTIPLE TIMES AFTER PATIENT BREATH WAS HELD AND LEVELS WERE MONITORED TO DEMONSTRATE BREATH HOLD. END USERS BELIEVE SYSTEM WASN¿T SETTING THE PHASE REFERENCE PROPERLY. TROUBLESHOOTING WAS PERFORMED. ANESTHESIA CONFIRMED THE PATIENT REMAINS PARALYZED, THERE WERE NO LIGHTS ON IN THE MRI BORE, THE OVERHEAD LIGHTS WERE OFF PER USUAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235408 ↗
• MalfunctionDec 8, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT THE CONNECTION BETWEEN THE SALINE TUBBING AND THE SALINE DRIP BAG WAS DAMAGED AND THEREFORE THEY WERE UNABLE TO USE THE DRIP BAG. IT WAS REPORTED THAT THE SITE USED A DIFFERENT RESERVOIR AND THE TEAM NOT HAVING TO OPEN A NEW KIT. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942566 ↗
• MalfunctionNov 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DAMAGE ESTIMATE WAS NOT PRESENTING AS IT TYPICALLY DID HISTORICALLY. TROUBLESHOOTING WAS PERFORMED. THE POSITIONING WAS CONFIRMED ON MAGNETIC RESONANCE IMAGING (MRI). THE MRI SCANNING SETTINGS WERE VERIFIED. THE LIVE TEMPERATURE MAP (TMAP) WAS VERIFIED. THE FIBER WAS REMOVED AND IT WAS CONFIRMED THAT THE DIFFUSING TIP WAS STILL INTACT. THEY ALSO INSERTED A NEW FIBER. THE PROBABLE CAUSE WAS THAT THE TARGET WAS INSULA THAT WAS PREVIOUSLY ABLATED TWICE. THE CATHETER WAS ADJACENT TO SYLVIAN FISSURE AND TWO SMALLER VESSELS. AFTER FURTHER DISCUSSION IT WAS DETERMINED THAT SYLVIAN WAS A PROBABLE HEAT SINK WHEREBY DIMINISHING THE EFFECTIVE HEATING/ABLATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888407 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THAT THE SOFTWARE ILT CAUSED IMAGES TO FLIP ON THE SCREEN. A TEMPORARY SOLUTION WAS TO OPEN THE IMAGES IN A DIFFERENT SECTION OF THE APPLICATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725573 ↗
• MalfunctionOct 27, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT A DAMAGE MAP WAS LOST DURING SURGERY WHEN STARTING A NEW SESSION USING THE 3.4 SOFTWARE AND CONNECTED TO A GE ILT SCANNER. A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THIS ISSUE OCCURS WHEN THIS SOFTWARE IS COMBINED WITH THIS SCANNER. THEY SAID THAT THE SOFTWARE FLIPS IMAGES MAKING IT SO DAMAGE MAPS ARE LOST. FLIPPING WAS EXPLAINED AS SAGITTAL AND AXIAL IMAGES SWAPPING PLACES. WHEN THE FLIP OCCURS, DAMAGE DATA IS LOST. THERE WERE A TOTAL OF FOUR SESSIONS. THE FIRST AND FOURTH SESSIONS, THE IMAGES SWAPPED. THE FIRST SESSION DID NOT HAVE BURN DATA, SO THE FLIPPING DID NOT CAUSE ANY BURN DATA TO BE LOST. HOWEVER THE FOURTH SESSION DID. THE SECOND AND THIRD SESSION PERFORMED AS EXPECTED. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681330 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM THAT WAS USED FOR A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD AN ADVERSE REACTION AFTER A THE NEURO ABLATION. THE PROCEDURE WAS ON (B)(6) 2022, AND THE PATIENT HAD A BILATERAL ABLATION WITH ONE LASER FIBER PLACED ON EACH SIDE OF THE HEAD. THERE WERE NO ISSUES DURING THE PROCEDURE, AFTER WHICH THEY WORE A WOOL CAP WITHOUT SHOWERING FOR TEN DAYS. AFTER THAT TIME THE PATIENT WAS READMITTED WITH AN INFECTION ON BOTH SIDES. THE SITES WAS DEBRIDED AND THE PATIENT WAS SENT HOME WITH NO FURTHER REPORTED COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 15319473 ↗
• MalfunctionJun 17, 2022Failure to Read Input Signal; Failure to Read Input Signal

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE NEURO ABLATION PROCEDURE. IT WAS REPORTED THAT THE 15MM DISPOSABLE LEAKED ONTO THE CENTRAL PROCESSING UNIT (CPU.) THE SITE DRIED IT IMMEDIATELY, BUT THE SYSTEM WAS NO LONGER FUNCTIONING. THE SYSTEM SHUT DOWN ON ITS OWN. THE SITE ABORTED THE USE OF THIS SYSTEM AND GRABBED THEIR OTHER THERMAL THERAPY SYSTEM TO FINISH OUT THE CASE. 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 14733620 ↗
• MalfunctionMay 20, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THE TUBING OF THE THERMAL THERAPY SYSTEM LEAKED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF FIVE MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453120 ↗
• MalfunctionApr 27, 2022Failure to Read Input Signal; Failure to Read Input Signal

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MAIN USER PASSWORD EXPIRED, HOWEVER WHEN THE MANUFACTURER REPRESENTATIVE(REP) WENT TO CHANGE THE PASSWORD IN MAINT, THEY WERE UNABLE TO LOGIN WITH THE MAINT PASSWORD. THE REP WAS ALSO UNABLE TO LOGIN TO ROOT. THE SYSTEM DID NOT GIVE THE REP ANY "INCORRECT PASSWORD" NOTIFICATIONS, IT LOOKED LIKE IT ATTEMPTED TO LOGIN THEN KICKED THEM BACK TO THE MAIN SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222738 ↗
• MalfunctionDec 2, 2021Failure to Read Input Signal; Failure to Read Input Signal

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT DURING CONFIGURATION WITH A DIFFERENT COMPANIES MRI SYSTEM THE SOFTWARE CRASHED WHILE IT WAS SAVING THE CONFIGURATION INFORMATION. THE ERROR MESSAGE SHOWED "SESSION MANAGER BUSY". THE ONLY ACTIVITY POSSIBLE WAS TO SWITCH OFF THE THERMAL THERAPY SYSTEM'S COMPUTER, BUT THE ERROR MESSAGE REMAINED ACTIVE WHEN THE COMPUTER WAS RESTARTED. AFTER KEEPING THE COMPUTER OFF FOR MORE THAN 30 MINUTES, THE MANUFACTURER REPRESENTATIVE TRIED TO SAVE THE INFORMATION AGAIN. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER 5 ATTEMPTS THE CONFIGURATION WAS ABLE TO BE SAVED. TWO CONFIGURATION WERE SAVED SINCE THE FIRST WAS NOT WORKING AND THE GATEWAY FIELD EVEN IF CORRECTLY TYPED WAS NOT SAVED AND RESULTED EMPTY. A SECOND CONFIGURATION WAS TRIED BUT AFTER SAVE DATA WAS TRIED TO CONNECT THE SYSTEM THE WHOLE SYSTEM OR SOFTWARE WAS BLOCKED. ANY KEY SELECTION RESULTED IN A MESSAGE INFORMING THAT THE SYSTEM MANAGES WAS BUSY. NO ACTION WAS ALLOWED EVEN TO SHUT DOWN THE SYSTEM CORRECTLY. ONLY A HARD SHUTDOWN WAS POSSIBLE DIRECTLY FROM THE COMPUTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917323 ↗
• MalfunctionNov 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE LASER FIBER WAS IMPLANTED WITH NO ISSUES IN THE OPERATING ROOM (OR). A CYST THAT WAS RIGHT NEXT TO THE TUMOR THAT WAS BEING ABLATED WAS DRAINED OF ~88 CC FLUID IN THE OR. THE PATIENT WAS THEN BROUGHT TO MAGNETIC RESONANCE IMAGING (MRI) TO SET UP FOR THE ABLATION. ONCE STARTED, THEY NOTICED THAT THE AREA BEING THE CYST WAS STARTING TO HEAT UP, AS IF THE HEAT WAS CROSSING OVER THE AIR IN THE FREE SPACE WHERE THE CYST HAD BEEN ASPIRATED. THE TEMPERATURE IN THIS AREA WAS CHANGING VALUES. THIS OCCURRED IN MULTIPLE ABLATION, AS THEY WERE PERFORMING PULL-BACKS. EVEN WHEN THEY HAD LET THE AREA COOL DOWN ON ONE OF THE PULL BACKS, IN THAT ONE AREA, IT WAS SHOWING THAT THE TEMPERATURE WAS HIGH. THIS CAUSED NO DELAY AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862452 ↗
• MalfunctionOct 15, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT THE TUBING KIT FOR THE SYSTEM HAD A PIN HOLE LEAK AT THE CONNECTION POINT TO AN EXTENSION SET. 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 12639037 ↗
• MalfunctionOct 8, 2021Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED IN A SOFT NEURO TISSUE ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598214 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181859. One submission often covers many models, so check the product and lot details in each record.

• Z-0244-2023 · Oct 14, 2022 · Open, Classified
  Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical