Acessa ProVu SystemRecalls & reported problems across all models

We found 5 models of Acessa ProVu System by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2023 and Sep 24, 2026 — classified as 1 death, 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

Most reported Acessa ProVu System problems

Acessa ProVu System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acessa ProVu System 7300

  COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
  1 death35 reports
• Acessa ProVu System 7700

  COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
  3 reports
• Acessa ProVu System 7100

  COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
  3 reports
• Acessa ProVu System 3000

  COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
  1 report
• Acessa ProVu System 5200

  COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
  1 report

Recent Acessa ProVu System adverse event reports

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

• InjurySep 24, 2026Insufficient Device Problem Information

  Patient problems: Pelvic Pain

  MAUDE report 50884622 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient received an Acessa Procedure on (b)(6) 2026, in which no concerns were observed during the procedure. Later the patient was admitted to the emergency room on (b)(6) 2026 due to exibiting abdominal pain, diarrhea, vomiting, fever and chills. Patient received 2 CT Scans that returned negative. Patient had modest elevated white blood count and was diagnosed with bacteremia, post op infection more specifically a gastrointestinal infection. Patient was reported as received antibiotics pre procedure and post procedure as well. Patient was later reported as doing well and no further treatment required. No other information available.

  Patient problems: Bacterial Infection; Chills; Diarrhea; Fever; Nausea; Vomiting

  MAUDE report 50083742 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2026, IN WHICH 3 FIBROIDS OF UNKNOWN SIZE WERE ABLATED. NO INJURIES NOR MEDICAL INTERVENTION WAS REPORTED REQUIRED DURING THE PROCEDURE AND THE PATIENT DID NOT HAD ANY PREVIOUS PROCEDURES NOR CONCOMITANT DEVICES USED. PATIENT HAD A PREVIOUS HISTORY OF HIGH BLOOD PRESSURE TREATED WITH AMLODIPINE AND OBSTRUCTIVE SLEEP APNEA. ON APRIL 23RD, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO PLEURAL EFFUSION. THE TREATING PHYSICIAN FROM THE CASE COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AND LINKAGE BETWEEN THE ACESSA PROCEDURE AND THE PLEURAL EFFUSION OBSERVED. THE PATIENT CONSULTED A PULMONOLOGIST THAT MENTIONED TO THE PATIENT WHICH IN HER OWN WORDS ¨ THAT DURING PROCEDURES INVOLVING HEAT TRANSFER THERE COULD BE PLEURAL EFFUSION AFTERWARDS¨. PATIENT WAS ADMITTED TO THE HOSPITAL AND KEPT FOR OBSERVATION RECEIVING CONTROL CHEST X-RAYS. NO MEDICATION WAS REPORTED TO HAVE BEEN ADMINISTERED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pleural Effusion

  MAUDE report 25366507 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT RECEIVED AN ACESSA PROCEDURE, THE PROCEDURE WAS REPORTED AS UNEVENTFUL AND THE SURGEON NOTICED A MARK ON THE BLADDER. AT THE TIME OF THE PROCEDURE, IT WAS REPORTED THAT A UROLOGY TEAM CONSISTING OF SURGEON, UROLOGIST AND SURGEON PROCTOR WERE PRESENT DURING THE PROCEDURE AND AGREED THAT IT WAS NOT LIKELY CAUSED BY THE ACESSA PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD REPORTED INCREASED URINARY FREQUENCY AND THAT NO FOLLOW UP TREATMENT WAS REQUIRED. ON APRIL 17TH, 2026, NEW INFORMATION WAS RECEIVED ON THE CASE. THE TREATING PHYSICIAN REPORTED THAT SHE ¨NOW BELIEVES THAT THE MARK OBSERVED HAD BEEN A THERMAL SPREAD AND THAT DURING A CYSTOSCOPY IT WAS OBSERVED SPREAD THROUGH THE BLADDER¨. PATIENT RECEIVED A FOLEY CATHETER FOR 1 WEEK AND WAS PLACED ON ANTIBIOTICS. PATIENT REQUIRED MULTIPLE VISITS FOR URINATION AND PAIN AND THEN HAD TO GO BACK TO THE UROLOGIST MONTHS AFTER FOR PAIN DURING URINATION. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Bladder Dysfunction; Burn(s); Pain

  MAUDE report 25165259 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT RECEIVED AN ACESSA PROCEDURE, THE PROCEDURE WAS REPORTED AS UNEVENTFUL AND THE SURGEON NOTICED A MARK ON THE BLADDER. AT THE TIME OF THE PROCEDURE, IT WAS REPORTED THAT A UROLOGY TEAM CONSISTING OF SURGEON, UROLOGIST AND SURGEON PROCTOR WERE PRESENT DURING THE PROCEDURE AND AGREED THAT IT WAS NOT LIKELY CAUSED BY THE ACESSA PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD REPORTED INCREASED URINARY FREQUENCY AND THAT NO FOLLOW UP TREATMENT WAS REQUIRED. ON APRIL 17TH, 2026, NEW INFORMATION WAS RECEIVED ON THE CASE. THE TREATING PHYSICIAN REPORTED THAT SHE ¨NOW BELIEVES THAT THE MARK OBSERVED HAD BEEN A THERMAL SPREAD AND THAT DURING A CYSTOSCOPY IT WAS OBSERVED SPREAD THROUGH THE BLADDER¨. PATIENT RECEIVED A FOLEY CATHETER FOR 1 WEEK AND WAS PLACED ON ANTIBIOTICS. PATIENT REQUIRED MULTIPLE VISITS FOR URINATION AND PAIN AND THEN HAD TO GO BACK TO THE UROLOGIST MONTHS AFTER FOR PAIN DURING URINATION. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Burn(s); Pain

  MAUDE report 25149746 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE BACK IN (B)(6) 2025 THE EXACT DATE IS UNKNOWN. THE PHYSICIAN REPORTED THAT AT THE TIME A PEDUNCULATED FIBROID HAD BEEN LEFT FOR LATER REMOVAL. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR THE REMOVAL OF THE PEDUNCULATED FIBROID AND AT THE TIME OF THAT SURGERY THE PHYSICIAN OBSERVED THAT THE SEROSAL LAYER OF THE UTERUS HAD A TEAR FROM THE PREVIOUS PROCEDURE AND SUTURE THE TEAR OF THE SEROSA LAYER WITHOUT COMPLICATIONS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24849077 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON AN UNKNOWN DATE. LATER IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A UTERINE RUPTURE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24505963 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE THE CUSTOMER EXPERIENCED ISSUES WITH THE 3D GUIDANCE AND THE LINES IN THE IMAGE WERE POOR AND INTERMITTENT FOR WHICH THE ULTRASOUND HANDPIECE WAS EXCHANGED (2 ULTRASOUND DEVICES USED) BUT THIS DIDN´T FIX THE ISSUE. PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE WITHOUT THE 3D GUIDANCE. ADDITIONAL INFORMATION WAS RECEIVED IT WAS REPORTED THAT THE CUSTOMER HAD PREVIOUSLY DROPPED THE TABLE TOP FIELD GENERATOR (TTFG) ON A PREVIOUS PROCEDURE AND THAT THEY HAD USED IT DURING THIS PROCEDURE.THE PROCEDURE AT THE TIME HAD BEEN REPORTED TO BE COMPLETED WITHOUT PROBLEMS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON A LATER DATE AND A BOWEL INJURY WAS FOUND. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 24461928 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE THE CUSTOMER EXPERIENCED ISSUES WITH THE 3D GUIDANCE AND THE LINES IN THE IMAGE WERE POOR AND INTERMITTENT FOR WHICH THE ULTRASOUND HANDPIECE WAS EXCHANGED (2 ULTRASOUND DEVICES USED) BUT THIS DIDN´T FIX THE ISSUE. PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE WITHOUT THE 3D GUIDANCE. ADDITIONAL INFORMATION WAS RECEIVED IT WAS REPORTED THAT THE CUSTOMER HAD PREVIOUSLY DROPPED THE TABLETOP FIELD GENERATOR (TTFG) ON A PREVIOUS PROCEDURE AND THAT THEY HAD USED IT DURING THIS PROCEDURE. THE PROCEDURE AT THE TIME HAD BEEN REPORTED TO BE COMPLETED WITHOUT PROBLEMS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON A LATER DATE AND A BOWEL INJURY WAS FOUND. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 24461915 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE THE CUSTOMER EXPERIENCED ISSUES WITH THE 3D GUIDANCE AND THE LINES IN THE IMAGE WERE POOR AND INTERMITTENT FOR WHICH THE ULTRASOUND HANDPIECE WAS EXCHANGED (2 ULTRASOUND DEVICES USED) BUT THIS DIDN´T FIX THE ISSUE. PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE WITHOUT THE 3D GUIDANCE. ADDITIONAL INFORMATION WAS RECEIVED IT WAS REPORTED THAT THE CUSTOMER HAD PREVIOUSLY DROPPED THE TABLETOP FIELD GENERATOR (TTFG) ON A PREVIOUS PROCEDURE AND THAT THEY HAD USED IT DURING THIS PROCEDURE.THE PROCEDURE AT THE TIME HAD BEEN REPORTED TO BE COMPLETED WITHOUT PROBLEMS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON A LATER DATE AND A BOWEL INJURY WAS FOUND. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 24461811 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE IN 2023 ON AN UNKNOWN DATE. THE PATIENT BECAME PREGNANT THIS PAST YEAR AND HAD A SPONTANEOUS POSTERIOR UTERINE RUPTURE. PATIENT IS DOING WELL. PRETERM PREMATURE RUPTURE OF MEMBRANES HAPPENED AT 35 WEEKS AROUND MID-(B)(6), THE EXACT DATE IS UNKNOWN, AND PATIENT RECEIVED A C-SECTION DUE TO BREECH AND THE POSTERIOR RUPTURE WAS FOUND AT THE TIME OF THE C-SECTION. BOTH BABY AND PATIENT HAVE BEEN REPORTED AS DOING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24349655 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A NOVASURE AND ACESSA PROCEDURE ON (B)(6) 2025, AND PATIENT PRESENTED WITH LOW GRADE FEVER ON (B)(6) 2025. THE PHYSICIAN PERFORMED AN ULTRASOUND AND NOTES AIR AND FLUID FOUND WITHIN THE ONE 4 CM FIBROID THAT HAD 3 ABLATIONS. THE NOVASURE PROCEDURE WAS PERFORMED FIRST FOLLOWED BY THE ACESSA PROCEDURE, NO COMPLICATIONS WERE NOTED WITH EITHER OF THE PROCEDURES. PATIENT IS IN THE HOSPITAL NOW FOR OBSERVATION. PER A CLINICAL DISCUSSION THE PATIENT WAS A 47-YEAR-OLD WHO HAD A ACESSA PROCEDURE HAD A4 TO 5-CENTIMETER TYPE 5 SEB SEROSAL FIBROID TREATED WITH APPROXIMATELY 4 ACTIVATIONS WITH NO CONCERNS IMMEDIATELY PRIOR TO ACCESS OF THE PATIENT HAD A NOVASURE PROCEDURE AGAIN WITH NO OBVIOUS COMPLICATIONS. APPROXIMATELY 10 DAYS LATER THE PATIENT WAS READMITTED WITH PAIN AND CT SCAN SHOWED A 4 BY 6 CENTIMETER ENHANCING FLUID COLLECTION. THE PATIENT IS NOT FEBRILE OR TENDER. AN ULTRASOUND CODE A SIMILAR FLUID COLLECTION HOWEVER, THE RADIOLOGIST WAS UNSURE IF THIS REPRESENTED AN ABSENCE. MRI IS ORDERED BUT NOT COMPLETED YET. THE PHYSICIAN WAS UNCERTAIN IF PROPHYLACTIC ANTIBIOTICS HAD BEEN ADMINISTERED PRIOR TO THE PROCEDURE. THE DISCUSSION WITH THE PHYSICIAN

  Patient problems: Fever

  MAUDE report 23990397 ↗
• MalfunctionJan 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2025, THERE A TABLETOP GENERATOR INDICATOR (TTFG) THAT WOULD NOT STAY ON AFTER THE TTFG WAS PLUGGED INTO THE SYSTEM. THE STAFF CHECKED THE TTFG CABLE AND THE TTFG PLACEMENT AND CONFIRMED BOTH WERE CORRECT. THE SYSTEM POWER CYCLED AND AN ERROR WAS RECEIEVED WHEN IT POWERED BACK ON THAT STATED GUIDANCE FAILURE, NO TRACKER AND THERE WAS NO GREEN CHECK ON SCREEN TO INDICATE THE TTFG WAS CONNECTED. THE SYSTEM POWER CYCLED MULTIPLE TIMES AND THE TTFG CABLE WAS UNPLUGGED AND RE-PLUGGED FROM BOTH THE SYSTEM AND THE TTFG WHICH DID NOT RESOLVE. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE WHERE NO 3D GUIDANCE COULD BE USED. AFTER TESTING THE SYSTEM ON SITE WITH ADDITIONAL EQUIPMENT, IT WAS DISCOVERED THAT THE ISSUE WAS WITH THE GENERATOR. THE TESTING SUCCESSFULLY CONNECTED THE TTFG TO THE UUI SYSTEM WITH THE SAME TTFG CABLE WITH NO ERRORS AND CONNECTION ISSUES. THE SYSTEM WORKED AS INTENDED AFTER SWITCHING THE CONSOLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977054 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE IT WAS REPORTED THAT THERE IS AN UTERINE THERMAL BURN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 23976836 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR PAIN 10 DAYS POST ACESSA PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THERE WAS NO BLEEDING BUT A LOT OF FIBROIDS. PATIENT WENT HOME THAT DAY WITH NO ISSUES. PER A CLINICAL DISCUSSION THE PATIENT IS A 42-YEAR-OLD WHO HAD FOUR TO FIVE FIBROIDS THAT WERE TREATED. THESE WERE APPROXIMATELY IN THE 4-CENTIMETER RANGE WITH MULTIPLE APPLICATIONS OF RADIO FREQUENCY ENERGY. THE PATIENT RETURNED TO THE HOSPITAL EMERGENCY ROOM APPROXIMATELY 10 DAYS LATER COMPLAINING OF PAIN CT SCAN SHOWED A 3.5 CM DEFECT IN THE ANTERIOR MYOMETRIUM COMPARABLE TO COAGULATIVE NECROSIS. THERE WAS NO FREE FLUID, AND THERE WAS SOME QUESTION AS TO WHETHER THIS DEFECT COMMUNICATED WITH THE ENDOMETRIAL CAVITY. THE WHITE BLOOD COUNT WAS NORMAL, AND THE PATIENT REMAINED STABLE WITH NO REBOUND TENDERNESS. THERE WAS NO EVIDENCE OF INFECTION AND ANTIBIOTICS WERE NOT STARTED. AFTER 2 DAYS IN THE HOSPITAL, THE PATIENT WAS IMPROVING AND FEELING BETTER AND WAS DISCHARGED HOME. PROPHYLACTIC ANTIBIOTICS WERE NOT USED. NO CONCOMITANT PROCEDURES WERE DONE. DISCUSSION OF THE USE OF PROPHYLACTIC ANTIBIOTICS IN THE CLINICAL TRIAL OCCURRED AND NOTED THIS MAY BE REASONAB

  Patient problems: Necrosis; Pain

  MAUDE report 23976797 ↗

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