Visualase 002-1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169584440), received between Mar 10, 2017 and Dec 10, 2020 — classified as 1 death, 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K081656); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT NEURO TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THE PATIENT POST-OPERATIVELY DEVELOPED AN INTRAVENTRICULAR HEMATOMA. IT WAS SUSPECTED BY THE SURGEON THAT THE ISSUE WAS CAUSED BY THE COOLING CATHETER HAVING A SHARP TIP AS OPPOSED TO A BLUNT ONE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: Hematoma

  MAUDE report 10983778 ↗
• MalfunctionAug 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SOFT NEURO TISSUE ABLATION PROCEDURE, THE DAMAGED MAP SHOWED THAT THERE WAS NO DAMAGE FOR ONE OF THE FOUR LASERS IN USE. THE SITE INCREASED THE WATTAGE OF THE TEST AND THERE WAS NO DAMAGE PRESENTED ON THE MODEL. THE SURGEON WAS NOTED TO HAVE PUT NEUROFORM IN THE BONE ANCHOR BEFORE LASER INSERTION BUT DID NOT FLUSH IT OUT PRIOR TO PLACING THE CATHETER AND LASER. ONCE THE CATHETER WAS REMOVED, NEUROFORM WAS REPORTED TO BE STUCK TO IT. ALL OTHER LASERS IN THE PROCEDURE WERE NOTED TO FUNCTION AS DESIGNED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8864450 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT, FOLLOWING A SOFT NEURO TISSUE ABLATION PROCEDURE, THE PATIENT EXPERIENCED DIZZINESS WHEN IN THE HOSPITAL AND AT DISCHARGE. IT WAS NOTED THAT THE DIZZINESS OCCURRED WHEN STANDING UP AT TIMES AND LAYING DOWN FOR A WHILE. THE DIZZINESS WAS NOTED TO HAVE LASTED ABOUT TWO WEEKS AND RESOLVED WITHOUT ADDITIONAL INTERVENTION. IT WAS NOTED THAT THE REPORTED ISSUE WAS RELATED TO THE ANESTHESIA AND THAT THE RELATIONSHIP TO THE PROCEDURE AND ABLATION SYSTEM WAS UNKNOWN.

  Patient problems: Dizziness

  MAUDE report 8715993 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT REPORTED INTERMITTENTLY FORGETTING THOUGHTS WHILE HAVING A CONVERSATION OR WHEN BEING DISTRACTED FROM THEIR TRAIN OF THOUGHT. THE PATIENT REPORTED THAT THIS HAD HAPPENED FOUR TIMES SINCE THE PROCEDURE. PER THE PI, THIS WAS NORMAL FOR EPILEPSY PATIENTS. THE PATIENT ALSO HAD MEMORY PROBLEMS POST-OPERATIVELY. NO DIAGNOSTIC TESTING OR PROCEDURES WERE DONE. NO MEDICATIONS WERE ADMINISTERED. PER THE INVESTIGATOR, THE RELATEDNESS TO THE PROCEDURE WAS UNKNOWN BUT THE EVENT WAS NOT RELATED TO THE THERMAL THERAPY SYSTEM. THE EVENT OUTCOME WAS UNRESOLVED WITH NO FURTHER ACTIONS PLANNED.

  Patient problems: Memory Loss/Impairment

  MAUDE report 8670096 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT POST-OPERATIVELY, DURING THE SECOND FOLLOW-UP VISIT, THE NEURO OPHTHALMOLOGIST NOTED A RIGHT SUPERIOR VISUAL FIELD DEFICIT. PER THE INVESTIGATOR, IT WAS NOTED THAT THIS MAYBE A RESULT OF EDEMA WHICH WAS EXPECTED TO RESOLVE. THE PATIENT DID NOT REPORT NOTICING THIS VISUAL FIELD DEFICIT. IT DID NOT INTERFERE WITH THEIR DAILY ACTIVITIES. THE DEFICIT WAS NOT NOTED ON THE PI'S CONFRONTATIONAL TESTING. NO DIAGNOSTIC TESTING OR PROCEDURES WERE DONE. NO MEDICATIONS WERE ADMINISTERED. RELATEDNESS TO THE PROCEDURE WAS UNKNOWN. PER THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE THERMAL THERAPY SYSTEM. THE EVENT WAS UNRESOLVED AND NO FURTHER ACTIONS WERE PLANNED.

  Patient problems: Visual Impairment

  MAUDE report 8666706 ↗
• MalfunctionMay 30, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SOFT NEURO TISSUE ABLATION PROCEDURE, THE LURE LOCK ON THE COOLING CATHETER WOULD NOT TIGHTEN. THE MALFUNCTION RESULTED IN THE LURE LOCK ROTATING FREELY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655964 ↗
• MalfunctionMay 15, 2019Insufficient Heating; Insufficient Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SOFT TISSUE ABLATION. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE VCLAS 001-4000 .4 MM CORE FIBER 10 MM TIP SET. THE LASER REPORTEDLY WOULDN'T FUNCTION, AND UPON FURTHER INSPECTION, IT WAS FOUND THAT THE SHEATHING INSIDE OF THE PACKAGING WAS DAMAGED. THEY SWITCHED TO ANOTHER KIT TO PROCEED. ISSUE OCCURRED INTRA/PERI-OPERATIVELY WITH 20 MINUTES DELAY TO SURGICAL TIME. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8613852 ↗
• MalfunctionMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MANUFACTURER REPRESENTATIVE REPORTED VIA A SURGEON THAT THEY WERE NOT SEEING THE DMAPS AS EXPECTED DURING A LASER INDUCED THERMAL THERAPY (LITT). WHILE THE THERMAL OVERLAY WAS SHOWING US TEMPERATURE CHANGES AND SPREAD, THE DAMAGE ESTIMATE IMAGES DID SHOW CHANGE, BUT NOT AS MUCH AS THE SURGEON EXPECTED. THEY RESTARTED THE SESSION, HOWEVER THE SAME BEHAVIOR CONTINUED. THEY STOPPED AND TOOK A POST-OP SCAN AND WERE ABLE TO CONFIRM THAT THE ACTUAL ABLATION WAS MORE THAT WHAT WAS BEING SHOWED ON THE SOFTWARE. THEY WERE HAPPY WITH THE ACTUAL ABLATION SHOWN. THERE WAS NO DELAY OR REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7364309 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. USE OF THERMAL THERAPY SYSTEM WAS REPORTED. THE STUDY STARTED IN 2012 AND ENDED IN 2016. 8 PATIENTS WITH HYPOTHALAMIC HAMARTOMA (HH) UNDERWENT THE LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR HH TREATMENT. BASED ON THE ARTICLE, THE MEAN AGE IS 19.1 (TABLE 1). NO GENDER INFORMATION PROVIDED. A TOTAL OF NINE CATHETER/LASER FIBER ASSEMBLIES WERE PLACED IN THE EIGHT PATIENTS. DEPENDING ON THE TARGETED TISSUE AND SURROUNDING STRUCTURES, WHICH CAN DISSIPATE HEAT DEFERENTIALLY SUCH AS CEREBROSPINAL FLUID (CSF) AND BLOOD VESSELS, UP TO A 2¿4 CM CIRCUMFERENTIAL, SPHERICAL ABLATION CAN BE ACHIEVED. THE INTENSITY OF THE LASER ENERGY AS WELL AS THE DURATION OF TREATMENT IS MANUALLY CONTROLLED BY THE SURGEON DURING THIS PROCEDURE. ALTHOUGH IT IS POSSIBLE TO DELIVER UP TO 15 W, =8 WIS DELIVERED FOR >90 S TO ANY PART OF THE HH, AND NEAR THE PLANE OF ATTACHMENT, NO =5 W IS DELIVERED FOR NO =30 S. THIS IS DUE TO RISK OF INJURY TO THE CONTIGUOUS HYPOTHALAMUS, MAMMILLARY BODIES, AND MAMMILLOTHALAMIC TRACT. THE ARRHENIUS CALCULATION MAY BE USED TO ESTIMATE THE SIZE OF THE LESION AT 10 S INTERVALS. THIS CALCULATION DERIVES A TEMPE

  Patient problems: Emotional Changes; Hematoma; Iatrogenic Source

  MAUDE report 7015202 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. USE OF THERMAL THERAPY SYSTEM WAS REPORTED. THE STUDY STARTED IN 2012 AND ENDED IN 2016. ARTICLE REPORTED A SHORT TERM MEMORY LOSS FOR PATIENT NO. 7 POSTOPERATIVELY ON TABLE 1. PATIENT'S AGE AT THE TIME OF TREATMENT WAS REPORTED AS (B)(6) OLD. NO GENDER INFORMATION PROVIDED. A TOTAL OF NINE CATHETER/LASER FIBER ASSEMBLIES WERE PLACED IN THE EIGHT PATIENTS. DEPENDING ON THE TARGETED TISSUE AND SURROUNDING STRUCTURES, WHICH CAN DISSIPATE HEAT DEFERENTIALLY SUCH AS CEREBROSPINAL FLUID (CSF) AND BLOOD VESSELS, UP TO A 2¿4 CM CIRCUMFERENTIAL, SPHERICAL ABLATION CAN BE ACHIEVED. THE INTENSITY OF THE LASER ENERGY AS WELL AS THE DURATION OF TREATMENT IS MANUALLY CONTROLLED BY THE SURGEON DURING THIS PROCEDURE. ALTHOUGH IT IS POSSIBLE TO DELIVER UP TO 15 W, =8 WIS DELIVERED FOR >90 S TO ANY PART OF THE HH, AND NEAR THE PLANE OF ATTACHMENT, NO =5 W IS DELIVERED FOR NO =30 S. THIS IS DUE TO RISK OF INJURY TO THE CONTIGUOUS HYPOTHALAMUS, MAMMILLARY BODIES, AND MAMMILLOTHALAMIC TRACT. THE ARRHENIUS CALCULATION MAY BE USED TO ESTIMATE THE SIZE OF THE LESION AT 10 S INTERVALS. THIS CALCULATION DERIVES A TEMPERATURE AT A GIVEN

  Patient problems: Iatrogenic Source; Memory Loss/Impairment

  MAUDE report 7015200 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDTRONIC REPRESENTATIVE REPORTED ON BEHALF OF THE SITE, THAT A PATIENT UNDERWENT A LASER INDUCED THERMAL THERAPY (LITT) PROCEDURE ON (B)(6) 2017 FOR EPILEPSY. THERE WERE NO REPORTED DELAYS TO THE PROCEDURE OR ISSUES WITH THE THERMAL THERAPY SYSTEM. THERE WAS A REPORTED MAGNETIC RESONANCE IMAGING (MRI) TECHNICAL DIFFICULTY WHERE SOFTWARE WASN¿T LOADING PROPERLY ON THE MRI MACHINE, AND THE COMPUTER HAD TO BE REBOOTED. FOLLOWING THE PROCEDURE, AT 10:10 AM, THE PATIENT WAS DIAGNOSED WITH THIRD NERVE PALSY OF THE LEFT EYE. THE PATIENT WAS REPORTED TO HAVE DIPLOPIA AND PTOSIS DUE TO THE THIRD NERVE PALSY. THE ADVERSE EVENT (AE) IS REPORTED TO BE SECONDARY TO RECEIVING THE THERMAL ABLATION PROCEDURE, BUT NOT RELATED/DUE TO THE THERMAL THERAPY SYSTEM ITSELF. ON (B)(6) 2017, THE PATIENT RECEIVED AN OPHTHALMOLOGY EXAMINATION. THE EXAM FINDINGS WERE REPORTED AS ABNORMAL AND CLINICALLY CONSISTENT WITH A LEFT THIRD NERVE PALSY - LEFT EYE LIMITED MOTILITY AND LIMITED LEFT EYE. THE PATIENT RETURNED ON (B)(6) 2017 FOR EVALUATION, AND PER THE NEUROLOGICAL EXAM, IT WAS CONFIRMED THAT THE PATIENT HAS A PARTIAL CNIII PALSY OF THE LEFT EYE. NO ACTIONS HAVE BEEN TAKEN TO TREAT THIS AE. NO FURTHER ACT

  Patient problems: Iatrogenic Source; Nerve Damage; Ptosis; Seizures; Visual Impairment

  MAUDE report 6832891 ↗
• InjuryAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY A MEDTRONIC REPRESENTATIVE AND REPORTS THE USE OF THE THERMAL THERAPY SYSTEM. THIS IS REPORT TWO OF TWO. SEE 1723170-2017-03302. PER THE ARTICLE, MR-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRGLITT) IS AN INCREASINGLY POPULAR NEUROABLATIVE METHOD FOR THE SURGICAL TREATMENT OF EPILEPSY PATIENTS. ALL PATIENTS PRESENTED WITH REFRACTORY EPILEPSY AND, DESPITE THEIR DIFFERENT ETIOLOGIES AND VARIABLE LOCATION OF THE EPILEPTOGENIC ZONES (EZS), ALL OF THEM DEMONSTRATED SOME BENEFIT FROM THIS NEUROABLATIVE PROCEDURE, AS DESCRIBED. (SEE TABLE 1 FOR DEMOGRAPHICS, OUTCOME, AND FOLLOW-UP.) A (B)(6) YEAR-OLD FEMALE PRESENTED WITH REFRACTORY EPILEPSY AND A LEFT ANTERIOR MESIAL TEMPORAL FOCUS WAS DEMONSTRATED AT PHASE II MONITORING CONGRUENT WITH LEFT MTS (FIG 4A). DUE TO A PROMINENT CHOROID PLEXUS JUST SUPERIOR TO THE ATROPHIC LEFT HIPPOCAMPUS (FIG 4B), THE LASER FIBER WAS STEREOTACTICALLY PLACED SLIGHTLY MORE INFERIOR THAN NORMALLY DESIRED TO AVOID HEMORRHAGE. THE ABLATION ZONE INCLUDED THE INFERIOR ASPECTS OF THE AMYGDALA AND THE INFERIOR PORTION OF THE HIPPOCAMPUS AND PARAHIPPOCAMPAL GYRUS (FIG 4C). HOWEVER, IT WAS NOT POSSIBLE TO EXTEND IT TO THE

  Patient problems: Iatrogenic Source; Memory Loss/Impairment; Seizures; Therapeutic Response, Decreased; Unspecified Infection

  MAUDE report 6790056 ↗
• DeathAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY A MEDTRONIC REPRESENTATIVE AND REPORTS THE USE OF THE THERMAL THERAPY SYSTEM. THIS IS REPORT ONE OF TWO. SEE 1723170-2017-03303. PER THE ARTICLE, MR-GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRGLITT) IS AN INCREASINGLY POPULAR NEUROABLATIVE METHOD FOR THE SURGICAL TREATMENT OF EPILEPSY PATIENTS. ALL PATIENTS PRESENTED WITH REFRACTORY EPILEPSY AND, DESPITE THEIR DIFFERENT ETIOLOGIES AND VARIABLE LOCATION OF THE EPILEPTOGENIC ZONES (EZS), ALL OF THEM DEMONSTRATED SOME BENEFIT FROM THIS NEUROABLATIVE PROCEDURE, AS DESCRIBED. (SEE TABLE 1 FOR DEMOGRAPHICS, OUTCOME, AND FOLLOW-UP.) A (B)(6)-YEAR-OLD FEMALE WITH SEIZURES SINCE 17 YEARS OF AGE, WITH A RIGHT OCCIPITAL OPEN LIP SCHIZENCEPHALY AND MULTIPLE PERIVENTRICULAR HETEROTOPIC NODULES (FIGS 7A, B). PRIOR PHASE II EVALUATION WAS PERFORMED YEARS EARLIER; HOWEVER, OPEN RESECTION WAS NOT PURSUED DUE TO THE RISK OF VISUAL LOSS. PERSISTENT SEIZURES AND PROGRESSIVE MEMORY LOSS DESPITE ANTI-EPILEPTIC DRUG (AED) AND VAGAL NERVE STIMULATOR (VNS) INTERFERED WITH WORK AND EDUCATION AND PROMPTED THE PATIENT TO SEEK LASER ABLATION. PROCEDURAL SEQUELA WERE LIMITED TO A LEFT SUPERIOR QUADRANT VISUAL DEFE

  Patient problems: Death; Iatrogenic Source

  MAUDE report 6790010 ↗
• InjuryMar 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A PATIENT HAD LONGER THAN USUAL SWELLING AFTER A LASER-INDUCED THERMAL THERAPY PROCEDURE WHICH WAS PREFORMED ON (B)(6) 2016. THE SWELLING LASTED FOR A MONTH BUT THE SURGEON SAID HE WAS USED TO AROUND TWO WEEKS. THERE HAD BEEN NO ISSUES DURING THE CASE WHICH TOOK PLACE ON (B)(6) 2016. MEDTRONIC WAS MADE AWARE OF THIS ON (B)(6) 2017. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: Iatrogenic Source; Swelling

  MAUDE report 6450591 ↗
• MalfunctionMar 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON REPORTED IRREGULAR HEATING DURING ONE OF THE LASER INDUCED THERMAL THERAPY SESSIONS. THE MEDTRONIC REPRESENTATIVE SUGGESTED TO THE SURGEON THAT A POSSIBLE CAUSE MAY HAVE BEEN NEARBY HEAT SINKS, HOWEVER HE REQUESTED THAT THE LASER BE TESTED. THE PATIENT TREATMENT WAS ABLE TO BE COMPLETED AS PLANNED WITH THE THERMAL THERAPY SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6397503 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081656. One submission often covers many models, so check the product and lot details in each record.

• Z-3251-2018 · Jun 1, 2018 · Terminated
  Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542