Genesys HTA System M00658001R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729809357), received between Nov 22, 2016 and Nov 11, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GENESYS HTA PROCEDURE WAS PERFORMED IN A PATIENT SUFFERING FROM AUB. AT ABOUT SIX MINUTES INTO THE ABLATION CYCLE, A SMALL AMOUNT OF FLUID MIGRATING FROM THE UTERINE CAVITY WAS NOTED. OUT OF ABUNDANCE OF CAUTION DOCTOR APPROPRIATELY STOPPED THE PROCEDURE. A SMALL AREA OF MUCOSAL BLANCHING ON THE CERVIX AT 4-6 O'CLOCK, WITH NO EVIDENCE OF VAGINAL OR ANY OTHER UNINTENDED THERMAL EFFECT WAS NOTICED, TREATED WITH APPLICATION OF SILVER SULFADIAZINE TOPICAL CREAM AND ESTRACE (ESTRADIOL) VAGINAL CREAM. THE INITIALLY OBSERVED UNINTENDED THERMAL EFFECT ON THE CERVIX COMPLETELY RESOLVED FIVE DAYS LATER.

  Patient problems: Burn(s)

  MAUDE report 15781515 ↗
• MalfunctionNov 3, 2020Power Problem; Appropriate Device Problem Term/Code Not Available; Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE UNIT SHUT DOWN AFTER POWERING ON. NO ERROR MESSAGE APPEARED ON THE SCREEN, ATTEMPTED REBOOT BUT IT DID NOT WORK. THE PHYSICIAN THEN DECIDED TO ABORTED THE PROCEDURE FOLLOWING THE ISSUE WITH THE DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777606 ↗
• MalfunctionJul 1, 2020Failure to Power Up; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 9, 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, THE MACHINE JUST SHUT OFF IN THE MIDDLE OF THE PROCEDURE. BIOMED ALSO EXPERIENCED AN ERROR 11. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10219752 ↗
• MalfunctionJan 21, 2020Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA CAPITAL WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, ERROR CODE 10 "INSUFFICIENT COOLING" APPEARED ON THE SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612790 ↗
• MalfunctionJan 10, 2020Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 16, 2019, THAT A GENESYS HTA CAPITAL WAS USED DURING A HYDROTHERMAL ABLATION PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, ERROR CODE 25 - COMMUNICATIONS WITH THE GUI WAS LOST OR INTERMITTENT WAS NOTED ON THE CONSOLE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9576247 ↗
• MalfunctionNov 21, 2019Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A FAULTY CASSETTE ERROR MESSAGE APPEARED ON THE CONSOLE. ANOTHER PROCEDURE SET WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356161 ↗
• MalfunctionOct 22, 2019Failure to Power Up; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A GENESYS HTA CONTROL UNIT WAS USED IN A HYDROTHERMAL ABLATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CONSOLE REBOOTED WITHOUT ANY BUTTONS PRESSED AND ERROR MASSAGES PRESS DEL TO RUN AND USB MASS STORAGE AUTO DETECTING APPEARED ON THE SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9218969 ↗
• MalfunctionOct 7, 2019Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA CAPITAL WAS USED IN A HYSTEROSCOPIC THERMAL ABLATION (HTA) PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS GIVING ERROR 38, A POWER RELATED ISSUE. THE DEVICE WAS UNPLUGGED AND PLUGGED BACK INTO A DIFFERENT SOURCE BUT STILL THE ERROR PERSIST. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163002 ↗
• MalfunctionOct 7, 2019Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA CAPITAL WAS USED IN A PROCEDURE PERFORMED ON (B)(6), 2018. REPORTEDLY, THREE PROCEDURE SETS WERE USED ALONG WITH THE CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THREE SUCCESSIVE FLUID LOSS ALARMS WERE NOTED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162939 ↗
• MalfunctionJun 12, 2017Smoking; Smoking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING HEATING UP PHASE OF THE PROCEDURE, THE CONTROL UNIT STARTED TO SMOKE WHEN THE SALINE FLUID LEAKED ONTO THE MACHINE WHILE IT POWERED UP. THE UNIT WAS IMMEDIATELY UNPLUGGED FROM THE ELECTRICAL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6633332 ↗
• MalfunctionMay 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT THE CONSOLE WENT DIRECTLY TO THE ABLATION PHASE. THEY WERE UNABLE TO GO BACK TO THE HYSTEROSCOPY PHASE. A NEW PROCEDURE SET WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6571997 ↗
• MalfunctionDec 13, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING HYSTEROSCOPY PHASE, THE PHYSICIAN WANTED TO PERFORM ADDITIONAL HYSTEROCOPY BUT THE MACHINE WENT DIRECTLY TO SEAL INTEGRITY CHECK PHASE WITHOUT TOUCHING OR PRESSING THE CONTROL BUTTONS. THE PROCEDURE WAS COMPLETED USING THE SAME CONSOLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6172631 ↗
• MalfunctionNov 22, 2016Device Alarm System; Application Program Problem; Device Operates Differently Than Expected; Device Alarm System; Application Program Problem; Device Operates Differently Than Expected

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION ENDOMETRIAL ABLATION SYSTEM WAS BEING TESTED ON (B)(6), 2016. ACCORDING TO THE COMPLAINANT, THE CONSOLE SKIPPED A PROCEDURAL STEP AT THE SEAL INTEGRITY CHECK PHASE, WENT TO COOL DOWN MODE AND REGISTERED AN INSUFFICIENT PATIENT COOLING MESSAGE.

  Patient problems: No Patient Involvement

  MAUDE report 6123058 ↗