Visualase 9735552Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169590076), received between May 15, 2018 and Jul 30, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. ARTICLE INDICATED THE USE OF THERMAL THERAPY SYSTEM. FOCAL LASER ABLATION IS A POTENTIAL TREATMENT IN SOME MEN WITH PROSTATE CANCER. CURRENTLY FOCAL LASER ABLATION IS PERFORMED BY RADIOLOGISTS IN A MAGNETIC RESONANCE IMAGING UNIT (IN BORE). WE EVALUATED THE SAFETY AND FEASIBILITY OF PERFORMING FOCAL LASER ABLATION IN A UROLOGY CLINIC (OUT OF BORE) USING MAGNETIC RESONANCE IMAGING-ULTRASOUND FUSION FOR GUIDANCE. A TOTAL OF 11 MEN WITH INTERMEDIATE RISK PROSTATE CANCER WERE ENROLLED IN THIS PROSPECTIVE, INSTITUTIONAL REVIEW BOARD APPROVED PILOT STUDY. MAGNETIC RESONANCE IMAGING-ULTRASOUND FUSION WAS USED TO GUIDE LASER FIBERS TRANSRECTALLY INTO REGIONS OF INTEREST HARBORING INTERMEDIATE RISK PROSTATE CANCER. THERMAL PROBES WERE INSERTED FOR REAL-TIME MONITORING OF INTRAPROSTATIC TEMPERATURES DURING LASER ACTIVATION. MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING (3 TESLA) WAS DONE IMMEDIATELY AFTER TREATMENT AND AT 6 MONTHS ALONG WITH COMPREHENSIVE FUSION BIOPSY. TEN OF 11 PATIENTS WERE SUCCESSFULLY TREATED WHILE UNDER LOCAL ANESTHESIA. MEAN PROCEDURE TIME WAS 95 MINUTES (RANGE 71 TO 105). POSTTREATMENT MAGNETIC RESO

  Patient problems: Hematuria

  MAUDE report 7733518 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. ARTICLE INDICATED THE USE OF THERMAL THERAPY SYSTEM. SEVENTY-ONE (71) PATIENTS WITH THE DIAGNOSIS OF GELASTIC EPILEPSY RELATED TO HH WERE TREATED AT A SINGLE CENTER WITH STEREOTACTIC LASER ABLATION FROM MARCH 11, 2011 TO FEBRUARY 9,2018. THERE WERE 46 MALES IN THE COHORT, AGES FROM 5 MONTHS TO 20 YEARS. SEVENTY-ONE (71) PATIENTS WITH THE DIAGNOSIS OF GELASTIC EPILEPSY RELATED TO HH WERE TREATED AT A SINGLE CENTER WITH STEREOTACTIC LASER ABLATION FROM MARCH 11, 2011 TO FEBRUARY 9,2018. THERE WERE 46 MALES IN THE COHORT, AGES FROM 5 MONTHS TO 20 YEARS. SIXTEEN PATIENTS, 25%, HAD FAILED OTHER SURGICAL OR RADIOSURGICAL INTERVENTIONS. AFTER STEREOTACTIC LASER ABLATION, 93% OF THE PATIENTS WERE FREE OF THEIR GELASTIC SEIZURES AT ONE YEAR, AND 78% OF THE PATIENTS WITH LESS THAN A YEAR OF FOLLOW-UP ARE FREE OF GELASTIC SEIZURES. TWENTY ONE OF THE PATIENTS IN THIS SERIES HAD SECONDARY SEIZURES THAT WERE LESSENED BY ABLATION AND CONTROLLED WITH MEDICINES. FOURTEEN OF THE PATIENTS, 20%, REQUIRED TWO ABLATIONS, AND 2 PATIENTS REQUIRED THREE ABLATIONS. MOST PATIENTS EXPERIENCE A NEAR INSTANT IMPROVEMENT IN THEIR CONDITION. 12% WERE

  Patient problems: Memory Loss/Impairment; No Code Available; Polydipsia; Seizures

  MAUDE report 7520685 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. ARTICLE INDICATED THE USE OF THERMAL THERAPY SYSTEM. FIFTEEN PATIENTS WERE INCLUDED FOR THIS STUDY. MEDIAN AGE WERE 66 YEARS. ALL PATIENTS TOLERATED THE PROCEDURE WELL WITH NO GRADE 3 COMPLICATIONS. 4 PATIENTS HAD GRADE 2 COMPLICATIONS (N=2 URINARY TRACT INFECTION, N=1 WORSENING LOWER URINARY TRACT SYMPTOMS, N=1 BILATERAL EPIDIDYMITIS. 8 PATIENTS HAD GRADE 1 COMPLICATIONS (N=5 GROSS HEMATURIA, N=3 MINOR GRADE 1 COMPLAINTS E.G. URGENCY, SMALL PRESSURE ULCER, POSTOPERATIVE FEVER). ALL EVENTS RESOLVED COMPLETELY. FOLLOW UP TARGETED BIOPSY REVEALED NO EVIDENCE OF CANCER IN N=10 PATIENTS, WHEREAS IN 5 PATIENTS FOLLOW UP BIOPSY WAS POSITIVE (N=3 HAD 2ND FLA SESSION, N=2 UNDERWENT PROSTATECTOMY). MPMRI GUIDED FLA IS SAFE AND FEASIBLE WITHOUT ANY SIGNIFICANT CHANGE IN URINARY AND SEXUAL FUNCTION WITH REASONABLE ONCOLOGIC RESULTS.

  Patient problems: Fever; Hematuria; Inflammation; Urinary Tract Infection

  MAUDE report 7520584 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. ARTICLE INDICATED THE USE OF LASER ABLATION SYSTEM. SURGICAL OUTCOMES OF A CONSECUTIVE SERIES OF 58 PATIENTS WITH MESIAL TEMPORAL LOBE EPILEPSY (MTLE) WHO UNDERWENT THE SURGERY AT OUR INSTITUTION WITH AT LEAST 12 MONTHS OF FOLLOW-UP WERE RETROSPECTIVELY EVALUATED, INCLUDING 33 FEMALES AND 25 MALES, RANGING IN AGE FROM 16 TO 67 YEARS (MEAN OF 40 YEARS) AT THE TIME OF FIRST SLAH. ALL PATIENTS WHO UNDERWENT STEREOTACTIC LASER AMYGDALOHIPPOCAMPOTOMY (SLAH) FOR MTLE BETWEEN JULY 1, 2011 AND JUNE 30, 2016. PATIENTS WHO WERE NOT FREE OF DISABLING SEIZURES FOLLOWING THE PROCEDURE WERE CONSIDERED FOR FURTHER SURGICAL INTERVENTION, INCLUDING OPEN RESECTION AND, FOR PATIENTS IN WHOM REVIEW OF AN INTERVAL POSTOPERATIVE MRI SCAN SHOWED A REMNANT REGION OF THE HIPPOCAMPUS AND/OR UNCUS THOUGHT TO BE RESPONSIBLE FOR ONGOING SEIZURES, REPEAT ABLATIONS. THE LATTER WERE PERFORMED IN A FASHION SIMILAR TO THE INITIAL ABLATION BUT FROM A MORE LATERAL ENTRY, TARGETING THE REMNANT MEDIAL TEMPORAL STRUCTURES. PATIENTS WHO FAILED A REPEAT ABLATION WERE AGAIN CONSIDERED FOR OPEN SURGICAL PROCEDURES. A TOTAL OF 67 LASER ABLATION PROCEDURE

  Patient problems: Hematoma; Intracranial Hemorrhage; Nerve Damage; Neurological Deficit/Dysfunction; Visual Impairment

  MAUDE report 7517355 ↗

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