Genesys HTA SystemRecalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 2 models of Genesys HTA System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Nov 11, 2022 — classified as 4 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (18 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 Genesys HTA System problems
Device problems
- Appropriate Device Problem Term/Code Not Available28
- Device Displays Incorrect Message18
- Device Alarm System7
- Adverse Event Without Identified Device or Use Problem3
- Device Operates Differently Than Expected3
- Power Problem3
- Failure to Power Up2
- Smoking2
Patient problems
- No Consequences Or Impact To Patient23
- No Known Impact Or Consequence To Patient8
- Burn(s)4
- No Patient Involvement1
- Superficial (First Degree) Burn1
Genesys HTA System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Genesys HTA System M006580010DEVICE, THERMAL ABLATION, ENDOMETRIAL24 reports
- Genesys HTA System M00658001R0DEVICE, THERMAL ABLATION, ENDOMETRIAL13 reports
Recent Genesys HTA System adverse event reports
The 15 most recent reports across all models, 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 20, 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, A HTA MACHINE DID NOT POWER UP FOR THE SCHEDULED HYSTEROSCOPY WITH HYDROTHERMAL ABLATION PROCEDURE. REPORTEDLY, NO ERROR MESSAGE OR CODE APPEARED ON THE CONSOLE. THEY TRIED A NEW CABLE AND ATTEMPTED ALL TROUBLESHOOT BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS ABORTED DUE TO NOT HAVING A REPLACEMENT DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10874610 ↗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 ↗MalfunctionOct 23, 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 OCTOBER 1, 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A LEAK ERROR MESSAGE WAS RECEIVED. REPORTEDLY, THERE WERE NO VISIBLE FLUID LEAKS NOTED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10725712 ↗MalfunctionSep 29, 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 THAT A GENESYS HTA CONTROLLER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE CONTINUOUSLY DISPLAYED A "CARTRIDGE ERROR" ON 3 CASSETTES USED. REPORTEDLY, THE HTA CONTROLLER HAS CAUSED THE ISSUE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENT REPORT WILL BE SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10601653 ↗MalfunctionSep 28, 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 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE UNIT WAS SHOWING CARTRIDGE ERROR. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10596878 ↗InjurySep 25, 2020Defective Device; Defective Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA CONTROLLER AND HTA PROCEDURE SET WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LABIA APPEARED TO HAVE A FIRST DEGREE BURN. REPORTEDLY, THERE WAS NO ISSUE WITH THE DEVICE AND NO ALARMS WERE DETECTED DURING THE PROCEDURE. THE BURN WAS TREATED WITH OINTMENT AT THE PHYSICIAN'S OFFICE.
Patient problems: Burn(s)
MAUDE report 10587371 ↗MalfunctionSep 9, 2020Device 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 GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN MENTIONED THAT THEY ARE UNSURE WHERE THE FLUIDS ARE GOING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF 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 10511289 ↗MalfunctionSep 8, 2020Device Alarm System; Device Displays Incorrect Message; Power Problem; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Device Displays Incorrect Message; 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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING HYSTEROSCOPY MODE, THE CONSOLE WENT BLACK WITHOUT WARNING, REBOOTED ITSELF AS IF THE ON AND OFF SWITCH HAD BEEN PRESSED AND RENDERED THE CASSETTE FAULTY. REPORTEDLY, THE PLUG BEING USED HAD A PIECE OF TAPE OVER IT. HOWEVER, THE PROCEDURE WAS CONTINUED WITH THE NEW CASSETTE AND DURING ABLATION MODE A BLACK SMUDGE THAT GREW QUICKLY WAS NOTICED ON THE END OF THE SCOPE. THE PHYSICIAN DID NOT HAVE VISUALIZATION OF THE CAVITY AND WENT INTO OVERRIDE COOLDOWN MODE. THE SEAL AND PLACEMENT WERE VERIFIED AND INITIATED ABLATION MODE. ABOUT TWO MINUTES INTO THE PROCEDURE, THE CONSOLE SHOWED AN ALARM OF NO FLOW AND INSTRUCTED TO CHECK FOR TISSUE OBSTRUCTION AND KINKS IN THE TUBING. THE UTERUS HAD CRAMPED DOWN OVER THE PROCEDURE SHEATH AND SEVERAL CLOTS WERE PRESENT IN THE TUBING, THE PHYSICIAN IDENTIFIED THIS AS THE CAUSE OF THE OBSTRUCTION AND DECIDED TO CONTINUE WITH THE ABLATION. AT ABOUT SIX MINUTES INTO THE ABLATION, THERE WAS AN ALARM OF FLUID LOSS OF 64CC/MIN. THE BAG OF FLUID WAS MANUALLY CALCULATING A ZERO DEFICIT
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10501357 ↗MalfunctionAug 19, 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 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN INCORRECT FLUID (SOLUTION) ERROR MESSAGE WAS RECEIVED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10428064 ↗MalfunctionAug 10, 2020Insufficient Cooling; Appropriate Device Problem Term/Code Not Available; Insufficient Cooling; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A GENESYS HTA 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE MACHINE WOULD NOT COOL DOWN. 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 10384941 ↗MalfunctionJul 27, 2020Installation-Related Problem; Appropriate Device Problem Term/Code Not Available; Installation-Related Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA CONTROLLER WAS USED TO PERFORM A HYDROTHERMAL ABLATION PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT WAS UNDER ANESTHESIA. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN WAS PRIMING THE MACHINE AND AN ERROR MESSAGE "CASSETTE FAILED" APPEARED. A SECOND CASSETTE WAS USED THE PHYSICIAN WAS UNABLE TO GAIN PRESSURE. THE HTA CASSETTE WAS REPRIMED AND IT FAILED FOR THE THIRD TIME. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10327276 ↗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 ↗MalfunctionApr 14, 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 115V CONTROL UNIT WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE CONSOLE SHOWED ERROR CODE 10 FAST PUMP. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT AND HOW THE PROCEDURE WAS COMPLETED DESPITE GOOD FAITH EFFORTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9957310 ↗MalfunctionMar 11, 2020Device Alarm System; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 24, 2019 THAT A GENESYS 115V HTA CAPITAL WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING THE COMPLAINANT, DURING THE PROCEDURE, THE CONSOLE SHOWS FLUID LOSS ERROR TWICE AND A CASSETTE ERROR ONCE. THE PROCEDURE WAS CANCELLED. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9819799 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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