Genesys HTA ProCerva M006580210 (UDI 00850033976038)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00850033976038), received between Mar 25, 2023 and Aug 26, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Use of Device Problem

  On July 29, 2026, Axora representative was informed of a post-procedure adverse event involving a Hydro Thermal Ablation (HTA) case on (b)(6) 2026. The procedure was completed successfully with no reported fluid loss; however, thermal burns to the patient's labia and vaginal side were identified two weeks later when the patient called reporting pain. The patient required follow-up medical treatment for wound care.

  Patient problems: Burn(s)

  MAUDE report 50459538 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, AN AXORA REPRESENTATIVE WAS NOTIFIED OF A POSSIBLE ADVERSE EVENT ASSOCIATED WITH AN HTA PROCEDURE THAT THE CONTROLLER ALERTED TO FLUID LOSS TWICE. AFTER THE PHYSICIAN RECEIVED THE THIRD FLUID LOSS ALARM, THE PHYSICIAN REMOVED THE SHEATH WITHOUT INITIATING THE COOL-DOWN PHASE. AS OF (B)(6) 2026, AXORA HAS COLLECTED ADDITIONAL EVENT DETAILS THAT A 44-YEAR-OLD FEMALE PATIENT WITH A DIAGNOSIS OF ABNORMAL UTERINE BLEEDING WAS SCHEDULED FOR ENDOMETRIAL ABLATION ON (B)(6) 2026. THE PROCEDURE INITIALLY INVOLVED AN ATTEMPT TO USE A NOVASURE PRODUCT, BUT IT DID NOT FUNCTION AS INTENDED. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO OBTAIN A CAVITY SEAL WITH NOVASURE. CONSEQUENTLY, THE PHYSICIAN ELECTED TO SWITCH TO THE GENESYS HTA PROCEDURE TO COMPLETE THE ABLATION. A LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP) WAS ALSO PERFORMED BEFORE THE HTA PROCEDURE WITHOUT COMPLICATION. UPON TRANSITIONING TO THE GENESYS HTA SYSTEM, THE HYDROTHERMAL ABLATION (HTA) SHEATH WAS PLACED WITHOUT DIFFICULTY, AND THE SEAL INTEGRITY CHECK INDICATED NO FLUID LOSS. HYSTEROSCOPY PERFORMED BEFORE THE HTA SHOWED NO EVIDENCE OF UTERINE PERFORATION. PER THE PHYSICIAN REPORT, DURING THE HYDROTHERMA

  Patient problems: Abdominal Pain; Bowel Perforation; Burn(s); High White Blood Cell Count; Uterine Perforation

  MAUDE report 25086577 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  ON JANUARY 13, 2026, MINERVA WAS MADE AWARE OF A PATIENT'S PERINEAL BURN ASSOCIATED WITH AN HTA PROCEDURE THAT WAS PERFORMED ON (B)(6) 2023 IN A 47-YEAR-OLD PATIENT SUFFERING FROM AUB. A NOVASURE PROCEDURE WAS ATTEMPTED FIRST BUT THE DOCTOR WAS UNABLE TO DEPLOY THE DEVICE, ABORTED THE NOVASURE PROCEDURE AND DECIDED TO PERFORM AN HTA PROCEDURE INSTEAD. ACCORDING TO THE MEDICAL PROVIDER, NO FLUID LEAKS WERE SEEN, NO ALARMS WERE REPORTED AND THE VAGINAL SPECULA WAS KEPT IN PLACE THROUGHOUT THE ENTIRE PROCEDURE. THE PROCEDURE WAS COMPLETED NOMINALLY. UPON COMPLETION THE PATIENT WAS TAKEN TO RECOVERY ROOM AND DISCHARGED SHORTLY THEREAFTER. A FEW DAYS AFTER THE PROCEDURE THE PATIENT WAS SEEN AT A LOCAL ED AND DIAGNOSED WITH A 2ND OR 3RD DEGREE THERMAL EFFECT ON THE PERINEUM. THE PATIENT WAS REFERRED TO A WOUND CLINIC WHERE THE AFFECTED AREA WAS MANAGED WITH APPLICATION OF TOPICAL OINTMENTS AND FISH SKIN GRAFT (FSG). ACCORDING TO THE DOCTOR THE PATIENT GOT BETTER, BUT REPORTED DISCOMFORT DURING INTERCOURSE.

  Patient problems: Burn(s)

  MAUDE report 24228880 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A GENESYS HTA ABLATION PROCEDURE WAS PERFORMED ON A PATIENT. A VAGINAL BURN WAS NOTED ON THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22382892 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A GENESYS HTA ABLATION PROCEDURE WAS PERFORMED ON A PATIENT. ACCORDING TO THE TREATING PHYSICIAN, NO FLUID LOSS ALERTS OR FLUID LEAKS WERE NOTICED DURING THE PROCEDURE. ON (B)(6) 2025 THE PATIENT WENT TO THE ER WHERE VAGINAL, CERVICAL AND PERINEAL THERMAL INJURIES WERE CONFIRMED. THE PATIENT WAS TREATED FOR PAIN AND WOUND CARE AND WAS DISCHARGED ON (B)(6) 2025. PATIENT ATTENDED THE POST-OPERATIVE APPOINTMENT ON (B)(6) 2025 AND WAS PRESCRIBED KEFLEX (10 DAY COURSE). SUBSEQUENTLY, THE PATIENT WENT TO THE ER ON (B)(6) 2025 FOR ABNORMAL UTERINE BLEEDING (AUB) AND PELVIC PAIN. A UTERINE ARTERY EMBOLIZATION (UAE) WAS COMPLETED, CULTURES OBTAINED, ANTIBIOTICS ADMINISTERED AND PAIN WAS MANAGED. PATIENT WAS DISCHARGED ON (B)(6) 2025.

  Patient problems: Burn(s); Pelvic Pain

  MAUDE report 22283156 ↗
• InjuryJan 8, 2025Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE PROCEDURE, DR. (B)(6) WAS HAVING TROUBLE GETTING A SEAL AND PACKED RAYTECS AROUND THE CERVIX TO GET A SEAL. THERE WERE TWO FLUID LOSS ALERTS DURING THE HTA PROCEDURE. THE VAGINA BURN WAS NOTICED RIGHT AWAY DURING THE PROCEDURE, AND THE PATIENT WAS REFERRED TO A SPECIALIST. IT WAS NOTED THAT THERE WAS ALSO A POLYPECTOMY WITH THE TRUCLEAR DEVICE PRIOR TO THE HTA PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 21106584 ↗
• InjurySep 19, 2024Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED A FLUID LEAK DURING THE PROCEDURE. THE SYSTEM DECLARED A LEAK ALARM AT APPROXIMATELY 3 MINUTES AND 30 SECONDS INTO THE ABLATION CYCLE. AROUND THIS TIME, THE PHYSICIAN NOTICED FLUID POOLING INTO THE VAGINAL CANAL. THE PROCEDURE WAS ABORTED. THE SYSTEM WENT THROUGH A 1 MINUTE AND 30 SECONDS COOL DOWN CYCLE PRIOR TO THE REMOVAL OF THE INSTRUMENTS. THE PHYSICIAN SAW THE PATIENT IN THE OFFICE POST OPERATIVELY AND NOTED A VAGINAL BURN AND A BURN TO THE RIGHT BUTTOCKS. THE PATIENT WAS PRESCRIBED VAGINAL CREAM, TOPICAL CREAM, AND PROPHYLACTIC ORAL ANTIBIOTICS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED A FLUID LEAK DURING THE PROCEDURE. THE SYSTEM DECLARED A LEAK ALARM AT APPROXIMATELY 3 MINUTES AND 30 SECONDS INTO THE ABLATION CYCLE. AROUND THIS TIME, THE PHYSICIAN NOTICED FLUID POOLING INTO THE VAGINAL CANAL. THE PROCEDURE WAS ABORTED. THE SYSTEM WENT THROUGH A 1 MINUTE AND 30 SECONDS COOL DOWN CYCLE PRIOR TO THE REMOVAL OF THE INSTRUMENTS. THE PHYSICIAN SAW THE PATIENT IN THE OFFICE POST OPERATIVELY AND NOTED A VAGINAL BURN AND A BURN TO THE RIGHT BUTTOCKS. THE PATIENT WAS PRESCRIBED VAGINAL CREAM, TOPICAL CREAM, AND PROPHYLACTIC ORAL A

  Patient problems: Burn(s)

  MAUDE report 20258999 ↗
• MalfunctionMar 25, 2023Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THE PROCERVA SHEATH TUBE DETACHED. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616736 ↗