NovaSure SureSound 2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 15420045501126), received between Oct 11, 2017 and Sep 24, 2026 — classified as 105 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (26 reports).

1 other recall cover devices cleared under the same FDA submission (P010013); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 151 reports, 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 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 ↗
• MalfunctionDec 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PROCEDURE COMPLETED AND WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, A TORN ARRAY WAS DISCOVERED. THERE WAS NO INJURY TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906457 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2025, A HYSTEROSCOPY WAS PERFORMED, AND NO PERFORATION WAS NOTED. WHEN NOVASURE DEVICE WAS INSERTED, IT DID NOT PASS THE CAVITY INTEGRITY ASSESSMENT TEST. THE SCOPE WAS THEN INSERTED, AND IT WAS NOTICED THAT THERE WAS A POSSIBLE PERFORATION ON THE FUNDUS. PATIENT IS SET TO GO TO RECOVERY AND BE SENT HOME. PROCEDURE WAS ABORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23877839 ↗
• MalfunctionDec 8, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THERE WAS A HOLE IN THE ARRAY AFTER THE ABLATION WAS COMPLETE. THE PROCEDURE WAS SUCCESSFUL WITH THE FIRST DEVICE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745767 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NOVASURE PROCEDURE OCCURRED ON (B)(6) 2025, AND THE PATIENT PRESENTED TO THE HOSPITAL THE NEXT DAY ON (B)(6) 2025, WITH SEPSIS. THE PHYSICIAN STATED THE PATIENT'S HEALTH IS POOR AND THERE ARE MANY OTHER CO-MORBIDITIES. THE PATIENT RECEIVED A MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2025 AND WAS ADMITTED TO THE HOSPITAL. BLEEDING HAS STOPPED. ADDITIONAL INFORMATION RECEIVED: THE PATIENT HAD MANY CO-MORBIDITIES AND WAS ANEMIC AND BLEEDING. THE PHYSICIAN PERFORMED UTERINE ARTERY EMBOLIZATION AND TRIED INTRA-UTERINE DEVICE WITH NO SUCCESS. FOLLOWING THE NOVASURE PROCEDURE, THE PATIENT PRESENTED WITH SEPSIS. PER A CLINICAL DISCUSSION, THE BACTERIA INDICATED WAS MORE COMMON WITH URINARY TRACT INFECTIONS AND THE PHYSICIAN STATED THAT ¨PERHAPS THE NOVASURE WAS NOT THE SOURCE OF THE INFECTION¨. THE BLADDER WAS ACCESSED POST THE NOVASURE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 23728032 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A NOVASURE PROCEDURE ON (B)(6) 2025. THE PATIENT PRESENTED ONE WEEK AFTER THE NOVASURE PROCEDURE ON (B)(6) 2025, WITH PAIN. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO HAVE A LAPAROSCOPY. LAPAROSCOPY REVEALED GREEN AND BLUE BLISTERS AND WHITE BLANCHING. THE PHYSICIAN DECIDED TO RESECT THE TISSUE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blister; Burn(s); Pain

  MAUDE report 23693392 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, DURING A NOVASURE PROCEDURE, THE CAVITY ASSESSMENT TEST FAILED TWICE BUT PASSED ON THE THIRD ATTEMPT. THE ABLATION WAS THEN COMPLETED. FOLLOWING THE PROCEDURE, THE PHYSICIAN PERFORMED A SEPARATE LAPAROSCOPIC PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN REPORTED PERFORATION AT THE FUNDUS. NO IMAGING, INTERVENTION OR MEDICATION WAS PROVIDED, AND THE PATIENT WAS DISCHARGED THE SAME DAY. UPON DISCHARGE THE PATIENT COMPLAINED OF DISCOMFORT AT THE LAPAROSCOPIC PROCEDURE SITE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Uterine Perforation

  MAUDE report 22984088 ↗
• MalfunctionAug 29, 2025Melted; Material Deformation; Melted; Material Deformation

  IT WAS REPORTED ON (B)(6) 2025 DURING A NOVASURE PROCEDURE, THE SHEATH WAS OBSERVED TO HAVE MELTED. THE ISSUE WAS NOTED AFTER THE PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTED DIFFICULTY IN REMOVING THE DEVICE DUE TO THE MELTED SHEATH, HOWEVER THE DEVICE WAS SUCCESSFULLY RETRACTED AND REMOVED WITHOUT PATIENT INJURY. THE DEVICE ARRAY WAS RETRACTED, AND REMOVAL WAS PERFORMED USING THE SAME DEVICE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22928916 ↗
• InjuryAug 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON (B)(6) 2025, DURING A LAPAROSCOPIC PROCEDURE, THE PHYSICIAN OBSERVED UTERINE PERFORATIONS AT THE FUNDUS AND POSTERIOR WALL. THE PHYSICIAN USED THE MEDAL SOUND AND THE SURESOUND DILATORS. FLUID WAS NOTED EXITING FROM THE FUNDAL PERFORATION SITE. THE PERFORATIONS WERE TREATED WITH A COAGULATION DEVICE AND HYSTEROSCOPY WAS COMPLETED. THE NOVASURE DEVICE WAS THEN INSERTED FOLLOWING A SUCCESSFUL CAVITY INTEGRITY ASSESSMENT AND THE ABLATION WAS PERFORMED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 22927697 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AUGUST 13TH, 2025 THAT THE PATIENT UNDERWENT A NOVASURE PROCEDURE ON (B)(6) 2025, PATIENT WAS LATER HOSPITALIZED WITH ABDOMINAL PAIN DUE TO SUSPECTED THERMAL INJURY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Abdominal Pain; Ascites; Burn(s); Decreased Appetite; Inflammation; Intermenstrual Bleeding

  MAUDE report 22927522 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2025, FOR A HISTORY OF ABNORMAL BLEEDING. THE NOVASURE PROCEDURE WAS REPORTED AS UNCOMPLICATED. LATER THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2025 WITH ABDOMINAL PAIN AND WAS DISCHARGED HOME WITH ANTIBIOTICS. THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL FOR 3 DAYS AND RECEIVED INTRAVENOUS ANTIBIOTICS ON THE SUSPICION OF ENDOMETRITIS. LATER SHE WAS ADMITTED TO THE HOSPITAL FROM (B)(6) FOR PAIN AND INFECTION. IMAGES ON (B)(6) SUGGESTED HEMATOMETRA/PYOMETRA AND A DILATION AND CURETTAGE CONFIRMED PYOMETRA. PATIENT WAS REPORTED AS BEING DISCHARGED AND STABLE AND COMPLETED ANTIBIOTICS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 22726003 ↗
• MalfunctionJul 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT AFTER A NOVASURE PROCEDURE WAS PERFORMED, THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN NOTICED A HOLE IN THE ARRAY MESH. THE PHYSICIAN SCOPED THE PATIENT POST PROCEDURE AND THERE WAS NO PATIENT INJURY AND THE PHYSICIAN WAS HAPPY WITH THE ABLATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644770 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010013. One submission often covers many models, so check the product and lot details in each record.

• Z-1094-2014 · Jan 24, 2014 · Terminated
  NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Contro