NovaSure SureSoundRecalls & reported problems across all models

We found 2 models of NovaSure SureSound by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 182 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2016 and Sep 24, 2026 — classified as 132 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (27 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 NovaSure SureSound problems

NovaSure SureSound models

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

• NovaSure SureSound 2013

  DEVICE, THERMAL ABLATION, ENDOMETRIAL
  151 reports
• NovaSure SureSound 2007

  DEVICE, THERMAL ABLATION, ENDOMETRIAL
  31 reports

Recent NovaSure SureSound 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

  It was reported that a Patient received a NovaSure and Acessa procedure in 2025 (Date unknown) without complications. Patient recently reported (in 2026) is experiencing extreme pain and was diagnosed with Post Ablation Syndrome confirmed by imaging per the physician. Patient does not desire a Hysterectomy and is receiving treatment for pain. Good Faith efforts completed and no additional information was received.

  Patient problems: Pelvic Pain

  MAUDE report 50884675 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a NovaSure procedure on (b)(6) 2026, during the procedure the customer was unable to pass the cavity integrity assessment, and when they were trying to seat the device a Bowel perforation ocurred. Procedure was aborted at this time and energy was never deployed from the NovaSure. Patient received a Colostomy and is in stable condition. No other information available.

  Patient problems: Bowel Perforation

  MAUDE report 50383105 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE IN THE WEEK OF (B)(6) 2026, WAS COMPLETED SUCCESSFULLY. THE PATIENT RETURNED TO THE PHYSICIAN ON (B)(6) 2026, WITH PAIN. THE PATIENT SPENT ONE DAY IN THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH ENDOMETRITIS INFECTION, URINARY TRACT INFECTION AND HEMORRHAGIC CYST ON THE RIGHT SIDE AND COLITIS ON THE LEFT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Colitis; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 25681721 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THEY WERE UNABLE TO PASS THE CAVITY INTEGRITY ASSESSMENT WITH A FIRST NOVASURE DEVICE INITIALLY THEN A SECOND DEVICE WAS USED AND COULD NOT PASS THE CAVITY INTEGRITY ASSESSMENT EITHER. THE CAVITY WAX EXAMINED AND A PERFORATION WAS DISCOVERED. THE PHYSICIAN DID NOT KNOW HOW THE PERFORATION HAPPENED. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Uterine Perforation

  MAUDE report 25447701 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE I ON (B)(6) 2023, THE PATIENT REPORTED THAT DURING THE PROCEDURE NO ISSUES WERE REPORTED AND THE PATIENT WAS SENT HOME THE SAME DAY. WITHIN 48 HOURS THE PATIENT REPORTED UNBEARABLE PAIN, SWEATING AND BECAME VERY PALE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WHERE AFTER IMAGING WAS PERFORMED A UTERINE PERFORATION AND BOWEL PERFORATION WAS OBSERVED. IT WAS REPORTED THAT LATER THE PATIENT ON (B)(6) 2023 WENT INTO SEPSIS AND REQUIRED A SURGERY TO REMOVE 6 INCHES OF SMALL INTESTINE AND INTUBATION AS WELL AS PARENTERAL NUTRITION. PATIENT REMAINED IN THE HOSPITAL FOR 3 WEEKS WHERE SHE RECEIVED THERAPY TO RECOVER. PATIENT REPORTED THAT AFTER THE SURGERY RELATED TO THE PERFORATION OF THE SMALL INTESTINE REQUIRED ADAPTATION AND LATER EXPERIENCED PELVIC PAIN AND BLEEDING ISSUES FROM THE UTERUS WHICH LATER REQUIRED A HYSTERECTOMY ON (B)(6) 2026. ON A FOLLOW UP THE PATIENT REPORTED THAT HER CONDITION HAD RETURNED TO NORMAL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bowel Perforation; Sepsis; Uterine Perforation

  MAUDE report 25444540 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE DEVICE WOULD NOT PASS THE CAVITY INTEGRITY ASSESSMENT TEST. THE PHYSICIAN THEN SCOPED THE PATIENT AND NOTICED A PERFORATION. THE PHYSICIAN WAS UNABLE TO CONFIRM IF THE PERFORATION WAS CAUSED BY THE NOVASURE DEVICE OR THE CURETTAGE PROCEDURE PERFORMED TO REMOVE A POLYP PRIOR TO USING THE NOVASURE DEVICE. THE PROCEDURE WAS ABORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 25338656 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THERE WAS A PERFORATION REPORTED. THE WIDTH WENT FROM 4 TO 5 CM. THE PATIENT IS STABLE AND SENT HOME. NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. THE PATIENT WILL BE RETURNING IN 2 MONTHS TO COMPLETE THE NOVASURE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24631872 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A SONATA AND NOVASURE PROCEDURE ON (B)(6) 2026. PHYSICIAN PERFORMED CONCOMITANTLY A LAPAROSCOPIC BILATERAL SALPINGECTOMY, DIAGNOSTIC HYSTEROSCOPY, DILATION AND CURETTAGE. AS WELL AS A PLANNED NOVASURE AND SONATA PROCEDURE. THE SONATA PROCEDURE WAS REPORTED AS NOT HAVING EXPERIENCED ISSUES, BUT THE NOVASURE WAS REPORTED AS HAVING TO USE 2 DEVICES. LATER THE PATIENT COMPLAINED OF FEVER AND CHILLS. PATIENT WAS TREATED WITH MOTRIN (IBUPROFEN) THE PATIENT CONTINUED TO EXPERIENCE SYMPTOMS AND WAS ADMITTED TO THE EMERGENCY ROOM FOR EVALUATION AND ULTIMATELY DISCHARGED. ON (B)(6) THE TEAM WAS NOTIFIED THAT THE PATIENT HAD BEEN ADMITTED WITH COLITIS AND BEING TREATED WITH ANTIBIOTICS AND IS BEING EXPECTED TO BE DISCHARGED DURING THE WEEK. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Chills; Fever

  MAUDE report 24619312 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A SONATA AND NOVASURE PROCEDUE ON (B)(6) 2026. PHYSICIAN PERFORMED CONCOMITANTLY A LAPAROSCOPIC BILATERAL SALPINGECTOMY, DIAGNOSTIC HYSTEROSCOPY, DILATION AND CURETTAGE AS WELL AS A PLANNED NOVASURE AND SONATA PROCEDURE. THE SONATA PROCEDURE WAS REPORTED AS NOT HAVING EXPERIENCED ISSUES BUT THE NOVASURE WAS REPORTED AS HAVING TO USE 2 DEVICES. LATER THE PATIENT COMPLAINED OF FEVER AND CHILLS. PATIENT WAS TREATED WITH MOTRIN(IBUPROFEN) THE PATIENT CONTINUED TO EXPERIENCE SYMPTOMS AND WAS ADMITTED TO THE EMERGENCY ROOM FOR EVALUATION AND ULTIMATELY DISCHARGED. ON MARCH 11TH THE TEAM WAS NOTIFIED THAT THE PATIENT HAD BEEN ADMITTED WITH COLITIS AND BEING TREATED WITH ANTIBIOTICS AND IS BEING EXPECTED TO BE DISCHARGED DURING THE WEEK. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Chills; Fever

  MAUDE report 24617952 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THAT THE MESH PART OF THE NOVASURE HANDPIECE FELL OFF AT THE END OF USING THE DEVICE OUTSIDE THE PATIENT AND EXPOSED THE METAL OF THE HANDPIECE. THE PHYSICIAN THEN INSERTED THE SCOPE AND REPORTED NO MESH WAS FOUND INSIDE THE PATIENT. THERE WAS NO ADDITIONAL INTERVENTION REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571725 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC RECEIVED A CASE REPORT NAMED ¨SEPSIS AFTER BIPOLAR RADIOFREQUENCY ENDOMETRIAL ABLATION¨ PUBLISHED IN THE OBSTETRICS & GYNECOLOGY JOURNAL IN AUGUST 2009. THE EXACT DATE OF THE EVENT IS UNKNOWN IN 2009. THE CASE WAS A PERIMENOPAUSAL WOMAN UNDERWENT AN ENDOMETRIAL ABLATION USING A BIPOLAR RADIOFREQUENCY DEVICE. SHE PRESENTED 36 HOURS POSTOPERATIVELY WITH SEPSIS. HER CONDITION WORSENED DESPITE 18 HOURS OF INTRAVENOUS ANTIBIOTICS AND AGGRESSIVE FLUID RESUSCITATION, AND SHE UNDERWENT EXPLORATORY LAPAROTOMY AND HYSTERECTOMY. BLOOD CULTURES AND UTERINE TISSUE CULTURES GREW ESCHERICHIA COLI. THE PATIENT IMPROVED QUICKLY AFTER HYSTERECTOMY. THE PATIENT WAS REPORTED AS HEALTHY, PERIMENOPAUSAL THAT RECEIVED AN UNREMARKABLE ABLATION CYCLE, BLOOD LOSS WAS MINIMAL AND NO ANTIBIOTIC PROPHYLAXIS WAS ADMINISTERED. PATIENT HAD A NEGATIVE ENDOMETRIAL BIOPSY AND PAP TEST PERFORMED 6 WEEKS BEFORE THE PROCEDURE. PATIENT PRESENTED TO THE URGENT LOCAL CARE 36 POSTOPERATIVELY WITH FEVER, CHILLS, VOMITING, DIARRHEA, AND GENERAL MALAISE. TEMPERATURE WAS 102.3 WITH BLOOD PRESSURES AROUND 80S/40S. BLOOD CULTURES WERE OBTAINED AND THE PATIENT WAS GIVEN INTRAVENOUS DOSES OF CLINDAMYCIN, GENTAMICIN, AND CE

  Patient problems: Diarrhea; Fever; Malaise; Pulmonary Edema; Sepsis; Vomiting

  MAUDE report 24349327 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026 THE PATIENT UNDERWENT A HYSTEROSCOPY, MYOSURE AND A NOVASURE PROCEDURE. AFTER SUCCESSFULLY COMPLETING THE HYSTEROSCOPY AND MYOSURE, THE PHYSICIAN PERFORMED NOVASURE ABLATION. THE PHYSICIAN WENT BACK INTO THE CAVITY AND NOTED THAT THE CERVIX HAS BEEN ABLATED AND NOT THE ENDOMETRIAL CAVITY. THE PHYSICIAN PRESCRIBED THE PATIENT WITH A TREATMENT POST OPERATION. THE PATIENT IS DOING WELL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 24307458 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PATIENT UNDERWENT HYSTEROSCOPY WITH NOVASURE. THE HYSTEROSCOPY WAS NORMAL AND NO FIBROIDS OR POLYPS WERE SEEN. THE NOVASURE SOUND WAS THEN USED TO GET THE CAVITY LENGTH. WHEN THE NOVASURE DEVICE WAS INSERTED, IT WAS CHALLENGING TO GET THE WAND TO OPEN PAST THE MINIMUM 2.5 CM REQUIREMENT. THE PHYSICIAN USED MULTIPLE METHODS TO GET THIS TO OPEN AND ON THE FINAL TRY THE WAND POPPED OPEN. THE CAVITY INTEGRITY ASSESSMENT TEST THEN FAILED. THE OPENING POP WAS REPORTED TO BE UNUSUAL SO THE PHYSICIAN REPEATED THE HYSTEROSCOPY. THE VIEW WAS LIMITED AND A PERFORATION WAS REPORTED NEAR THE FUNDUS ON THE PATIENT'S RIGHT SIDE. THE PROCEDURE WAS ABORTED. THE PATIENT WAS KEPTIN THE OFFICE FOR OVER AN HOUR. UPON DISCHARGE, THE VITALS WERE STABLE AND THERE WAS NO PAIN REPORTED. THE PATIENT CALLED SEVERAL HOURS LATER WITH SEVERE PAIN AND A SYNCOPAL EPISODE AT HOME. THE PATIENT WAS SENT TO EMERGENCY ROOM FOR FURTHER EVALUATION. IT WAS FOUND THAT THE PATIENT HAD HEMOPERITONEUM AND FALLING HEMOGLOBIN AND HEMATOCRIT AND WAS ADMITTED FOR THE NEXT 48 HOURS WITH SERIAL HEMOGLOBIN AND HEMATOCRIT WHICH DID NOT STABILIZE AT A HEMOGLOBIN OF 7. DEC

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Uterine Perforation

  MAUDE report 24135717 ↗
• MalfunctionJan 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE SURGEON REPORTED THAT AFTER THE ABLATION OPENED THE ARRAY AND OBSERVED A HOLE IN IT. NO INJURY TO THE PATIENT REPORTED. PROCEDURE WAS COMPLETED USING CAUTERY DEVICE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122366 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE CAVITY ASSESSMENT TEST FAILED. SECOND TENACULUM AND VASELINE GAUZE WAS ATTEMPTED AND THE SAME ISSUE OCCURRED. BLOOD WAS NOTED IN THE WIDTH DIAL. SECOND DEVICE WAS USED AND THE SAME ISSUE OCCURRED. PROCEDURE WAS THEN ABORTED. PHYSICIAN WENT INTO THE CAVITY VIA HYSTEROSCOPY AND NO PERFORATION WAS NOTED. THEN THE PHYSICIAN WENT INTO THE ABDOMEN VIA LAPAROSCOPY AND NOTICED A SMALL MARK ON THE UTERUS. THE UTERUS HELP THE DISTENTION AND DID NOT LEAK INTO THE ABDOMINAL CAVITY. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 24122257 ↗

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