NovaSure NS2013USRecalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 15420045501119), received between Aug 4, 2017 and Jul 10, 2026 — classified as 58 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Material Puncture/Hole

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE ABLATION AND PROCEDURE WAS COMPLETED. UPON REMOVING THE DEVICE FROM THE PATIENT, THE PHYSICIAN NOTED A HOLE IN THE ARRAY. THE PHYSICIAN THEN SCOPED THE PATIENT AND NO PERFORATION AND NO PARTICLES FROM THE ARRAY WERE FOUND. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25779624 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN OBSERVED A SMALL AREA OF DAMAGE ON THE PATIENT'S VAGINAL TISSUE DURING THE CONCLUSION OF THE NOVASURE PROCEDURE. THE PROCEDURE INCLUDED A HYSTEROSCOPY WITH POLYPECTOMY, REMOVAL OF A SMALL FIBROID AND A NOVASURE PROCEDURE. THE PHYSICIAN NOTED THAT THE DAMAGE MAY HAVE OCCURRED DURING REMOVAL OF THE DEVICE. UPON FURTHER EVALUATION, THE AREA APPEARED TO BE DISCOLORED AND SLIGHTLY DAMAGED. THE PHYSICIAN COULD NOT CONFIRM THE DAMAGE BUT POSSIBLY THOUGHT IT WAS A LITTLE BURN. THE AREA OF DISCOLORATION WAS NOTED ON THE PATIENT'S RIGHT INNER LABIA. THE PHYSICIAN INJECTED LIDOCAINE INTO THE AFFECTED AREA. NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25624416 ↗
• MalfunctionJun 12, 2026Material Puncture/Hole

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE ARRAY WAS FULLY OPENED INSIDE THE PATIENT, BUT THE ARRAY LIGHT WOULD NOT GO OFF. ANOTHER DEVICE WAS OPENED AND USED DURING THE PROCEDURE. UPON REMOVAL OF THE DEVICE, IT WAS REPORTED THAT THERE IS A HOLE IN THE ARRAY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487959 ↗
• 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 25447694 ↗
• MalfunctionMay 5, 2026Material Puncture/Hole

  IT WAS REPORTED THAT POST A NOVASURE PROCEDURE ON (B)(6) 2026, THAT WHEN THE PROCEDURE WAS COMPLETE, A HOLE IN THE MESH WAS NOTED. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086602 ↗
• 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 24122242 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, A CHECK WAS PERFORMED WITH A HYSTEROSCOPY AND EVERYTHING LOOKED NORMAL. THE CAVITY INTEGRITY ASSESSMENT TEST PASSED ON THE FIRST TRY. THE ABLATION LASTED AROUND A MINUTE. PATIENT RECOVERED WELL IN THE POST OPERATION AND WAS DISCHARGED AND SENT HOME THE SAME DAY. LATER THAT NIGHT, IT WAS REPORTED THAT THE PATIENT WAS IN A LOT OF PAIN AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL BUT ON (B)(6) 2025, THE PATIENT WAS BACK AT THE HOSPITAL WHERE IT WAS NOTICED THAT SHE HAD A BRUISE ON THE BOWEL BUT NO SIGNED OF PERFORATION WAS NOTED. ON (B)(6) 2025, SURGERY WAS DONE AND A SMALL PIECE OF BOWEL WAS REMOVED. PATIENT IS NOW RECOVERING WELL AT THE HOSPITAL ON A SPECIAL DIET AND TAKING ANTIBIOTICS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bowel Burn; Pain

  MAUDE report 23877952 ↗
• MalfunctionDec 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2025, AFTER THE PROCEDURE THE PHYSICIAN DISCOVERED A LARGE AMOUNT OF TISSUE IN THE LOWER PORTION OF THE ARRAY. NO PATIENT HARM OBSERVED. NOTED A HOLE IN THE MESH ARRAY UPON REDEPLOYING POST OPERATION. PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839050 ↗
• InjuryDec 11, 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, THAT THE FIRST DEVICE WAS TESTED OUTSIDE OF THE PATIENT. WHEN THE HANDLE WAS SQUEEZED, AN ARRAY ALARM TRIGGERED. A SECOND DEVICE WAS THEN OPENED AND TESTED OUTSIDE THE PATIENT; THE SAME ARRAY ALARM OCCURRED. THE DEVICE WAS INSERTED TO THE PATIENT AND AGAIN TRIGGERED THE ARRAY ALARM. THE PHYSICIAN REMOVED THE DEVICE AND EXAMINED THE UTERINE CAVITY USING A HYSTEROSCOPE, CONFIRMING A PERFORATION. THE PROCEDURE WAS STOPPED AND NO FOLLOW UP TREATMENT OR MEDICATION WAS REQUIRED. A REPLACEMENT DEVICE WAS REQUESTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23779162 ↗
• MalfunctionOct 30, 2025Application Program Freezes or Fails to Launch

  ERROR MESSAGE MID PROCEDURE. DEVICE WOULD NOT MOVE PAST ANALYZING STEP AND COULD NOT TROUBLESHOOT OR GET TO FUNCTION. OPENED AND USED A NEW UNIT TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23423788 ↗
• MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A NOVASURE PROCEDURE THE PHYSICIAN COMPLETED THE PROCEDURE AND REMOVED THE DEVICE TO SEE A TORN ARRAY. PHYSICIAN LOOKED INTO THE CAVITY AND NO HARM TO THE PATIENT REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369469 ↗
• MalfunctionOct 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ON (B)(6) 2025, THAT POST A NOVASURE PROCEDURE THERE WAS A HOLE IN THE BOTTOM OF THE ARRAY. THE HOLE IS APPROXIMATELY 1.5 CM IN DIAMETER. IT WAS CONFIRMED THAT THE ABLATION LOOKS NORMAL AND THERE WERE NO FOREIGN OBJECTS LEFT BEHIND. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325221 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AUGUST 6TH, 2025 THAT THE PHYSICIAN USED TWO NOVASURE DEVICES. THE FIRST DEVICE USED RECEIVED A VACUUM ALARM AFTER THE COLLECTION CANNISTER FILLED WITH BLOOD AND THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. AFTER 12 HOURS POST PROCEDURE THE PATIENT WAS EXPERIENCING FEVER AND CHILLS. A CULTURE WAS PERFORMED AND IT WAS CONFIRMED AFTER 48 HOURS THAT THE PATIENT HAD A GROUP B STREPTOCOCCUS SEPSIS. THE PATIENT IS IN GOOD CONDITION AND WAS RELEASED ON (B)(6) 2025 AFTER RECEIVING INTRAVENOUS ANTIBIOTICS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 22805346 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AUGUST 6TH, 2025 THAT THE PHYSICIAN USED TWO NOVASURE DEVICES. THE FIRST DEVICE USED RECEIVED A VACUUM ALARM AFTER THE COLLECTION CANNISTER FILLED WITH BLOOD AND THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. AFTER 12 HOURS POST PROCEDURE THE PATIENT WAS EXPERIENCING FEVER AND CHILLS. A CULTURE WAS PERFORMED AND IT WAS CONFIRMED AFTER 48 HOURS THAT THE PATIENT HAD A GROUP B STREPTOCOCCUS SEPSIS. THE PATIENT IS IN GOOD CONDITION AND WAS RELEASED ON (B)(6) 2025 AFTER RECEIVING INTRAVENOUS ANTIBIOTICS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 22805259 ↗
• InjuryJun 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER A NOVASURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT AFTER EXAMINING THE NOVASURE THE SHEATH OF THE DEVICE WAS CRUMPLED AND THE ARRAY WAS UNABLE TO BE FULLY CLOSED. PHYSICIAN ATTEMPTED TO REOPEN MULTIPLE TIMES AND USED A UTERINE SOUND TO FURTHER DILATE THE CERVIX AND WAS ABLET TO SUCCESSFULLY REMOVE THE DEVICE FROM THE PATIENT. NO PATIENT INJURY REPORTED. PHYSICIAN EXAMINED THE CAVITY AND OBSERVED 2 PIECES OF MATERIAL IN THE CAVITY THAT WERE SUCCESSFULLY REMOVED. AN X-RAY WAS PERFORMED AFTER REMOVING THE MATERIAL TO CONFIRM THAT NOTHING REMAINED IN THE UTERUS. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22141577 ↗
• MalfunctionMay 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT AFTER THE ABLATION THEY OBSERVED A HOLE IN THE ARRAY AND THAT WIRES WERE EXPOSED. NO PATIENT INJURY REPORTED AND THE EVENT WAS DESCRIBED AS COMPLETED SUCCESSFULLY, PHYSICIAN WENT BACK IN TO CHECK FOR ANY ISSUES AND DID NOT OBSERVE ANY. NO MEDICAL INTERVENTION REQUIRED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060671 ↗
• MalfunctionMar 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE MESH WAS FOUND TO BE TORN AT THE END OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635496 ↗
• MalfunctionMar 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE MESH WAS FOUND TO BE TORN AT THE END OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635462 ↗
• InjuryJan 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PATIENT EXPERIENCED A LABIAL BURN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 21231599 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT THE FIRST DEVICE COMPLETED THE ABLATION BUT THE PHYSICIAN WENT IT WITH A SCOPE AND SAW NO BURN, FOR WHICH HE USED A SECOND DEVICE BUT DID NOT PASS INITIAL CAVITY ASSESSMENT. THE PHYSICIAN USED A ROLLERBALL BETWEEN DEVICES. AFTER THE PROCEDURE THE PATIENT WAS HEMORRHAGING FOR WHICH ENDED UP REQUIRING A HYSTERECTOMY. IT IS UNKNOWN THE CAUSE OF THE HEMORRHAGE AT THE TIME OF THIS REPORT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21208455 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT THE FIRST DEVICE COMPLETED THE ABLATION BUT THE PHYSICIAN WENT IT WITH A SCOPE AND SAW NO BURN, FOR WHICH HE USED A SECOND DEVICE BUT DID NOT PASS INITIAL CAVITY ASSESSMENT. THE PHYSICIAN USED A ROLLERBALL BETWEEN DEVICES. AFTER THE PROCEDURE THE PATIENT WAS HEMORRHAGING FOR WHICH ENDED UP REQUIRING A HYSTERECTOMY. IT IS UNKNOWN THE CAUSE OF THE HEMORRHAGE AT THE TIME OF THIS REPORT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21208380 ↗
• MalfunctionJan 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT AFTER A SUCCESSFUL ABLATION, THE ARRAY WAS OBSERVED AS DAMAGED/TORN. THE PHYSICIAN EXAMINED THE CAVITY AND NO INJURIES OBSERVED AND THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY. NO PATIENT IMPACT OR HARM REPORTED AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182760 ↗
• MalfunctionNov 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER COMPLETING A NOVASURE ABLATION, THE PHYSICIAN OBSERVED THAT THE MESH OF THE ARRAY WAS TORN. HYSTEROSCOPY WAS PERFORMED AND THE PHYSICIAN VISUALLY CONFIRMED THAT NO MESH HAD BEEN RETAINED IN THE UTERUS. NO POST OP TREATMENT WAS GIVEN TO THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798489 ↗
• MalfunctionNov 25, 2024

  THE NOVASURE DEVICE KIT ISN'T WORKING PROPERLY WITH REF NUMBER OF NS2013US WITH LOT# OF 2460212.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771068 ↗
• MalfunctionNov 20, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2024, AFTER THE PROCEDURE THE PHYSICIAN OBSERVED A HOLE IN THE ARRAY. THE ABLATION WAS REPORTED AS COMPLETED. A SMALL FIBER FROM THE MESH WAS FOUND IN THE CAVITY AFTER THE ABLATION AND WAS ABLE TO BE REMOVED SUCCESSFULLY WITH A 5 FRENCH TOOL. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740097 ↗

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