NovaSureRecalls & reported problems across all models

We found 5 models of NovaSure by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 344 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2016 and Aug 12, 2026 — classified as 2 deaths, 183 injuries, 159 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (78 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 problems

NovaSure models

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

• NovaSure NS2013US

  DEVICE, THERMAL ABLATION, ENDOMETRIAL
  112 reports
• NovaSure V5

  Device, thermal ablation, endometrial
  2 deaths92 reports
• NovaSure NS2000US

  DEVICE, THERMAL ABLATION, ENDOMETRIAL
  77 reports
• NovaSure V5

  Device, thermal ablation, endometrial
  60 reports
• NovaSure NovaSure Controller

  DEVICE, THERMAL ABLATION, ENDOMETRIAL
  3 reports

Recent NovaSure adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the physician used the MyoSure Lite device prior to the NovaSure procedure on (b)(6) 2026. During a NovaSure procedure that physician inserted that NovaSure device but could not get the array to open. The physician reseated the device four to five times. Blood was noted in the width dial. The physician then opened the second NovaSure device but unable to get the width dial out of red. The physician did a lot of back and forth and side to side movements. After trying to reseat it two to three times, it popped open, but the physician felt it was too wide. The physician inserted the scope to view cavity and identified a uterine perforation. Upon laparoscopy, which was already planned for salpingectomy, confirmed uterine perforation. The physician then used a LigaSure generator to cauterize perforation site. It was confirmed that the second NovaSure device caused the perforation. The procedure was aborted. No other information is available.

  Patient problems: Uterine Perforation

  MAUDE report 50227419 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a NovaSure procedure was completed on an unknown date. The physician also performed hysteroscopy during the NovaSure procedure. The patient was admitted to the emergency room the day after the procedure with extreme pain. The patient was treated for the pain symptoms and was discharged after 24 hours. The patient is doing well, and no additional treatment was needed. No other information is available.

  Patient problems: Pain

  MAUDE report 50071530 ↗
• MalfunctionJul 10, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25780839 ↗
• 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 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOSURE PROCEDURE FOR POLYP REMOVAL. ONCE THE POLYP RESECTION WAS COMPLETED, THE CAVITY APPEARED INTACT. THE PATIENT WAS THEN UNDERGOING A NOVASURE PROCEDURE, WHERE THE CAVITY INTEGRITY ASSESSMENT (CIA) TEST TOOK 15 SECONDS TO PASS AND THE ABLATION BEGAN. ABOUT 25 SECONDS INTO THE ABLATION CYCLE, THE BLOOD QUICKLY BEGAN TO INFILITRATE THE NOVASURE TUBING PASSING THE DESICCANT FILTER WHICH LED TO A VACUUM FAILURE ALERT AT 40 SECONDS. THE PHYSICIAN REMOVED THE DEVICE TO INSPECT AND SAW NO ISSUES AND PROCEEDED BY USING A SOUND TO TAP THE VACUUM RELIEF VALVE AND REINSERTED AND RESEATED THE DEVICE. UPON THE CIA WITH THE SAME DEVICE, THE BLOOD BECAME PRESENT IN THE WIDTH DIAL AND THE CIA TEST FAILED. HYSTEROSCOPIC EVALUATION WAS PERFORMED AND DID NOT INITIALLY REVEAL EVIDENCE OF PERFORATION. A SECOND NOVASURE DEVICE WAS ATTEMPTED BUT THE CIA TEST FAILED AGAIN AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR BILATERAL SALPINGECTOMY. DURING A FOLLOW UP LAPAROSCOPY WAS IDENTIFIED A MINOR UTERINE PERFORATION. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE. IT WAS LATER NOTED THAT THE PATIENT WAS 4 MONTHS POSTPARTUM

  Patient problems: Uterine Perforation

  MAUDE report 25599605 ↗
• MalfunctionJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2026. PRIOR PROCEDURE A HYSTEROSCOPY WAS PERFORMED TO REMOVE A 2 MM POLYP USING GRASPERS. AFTER THE ABLATION THE PHYSICIAN NOTICED A HOLE IN THE ARRAY IN THE POSTERIOR SECTION, PATIENT EXAMINED THE CAVITY VIA HYSTEROSCOPE AND FOUND VISIBLE GOLD FLAKES IN CAVITY. PHYSICIAN USED A CURETTE AND SCRAPED THE RESIDUES OUT OF THE CAVITY. ALL REMAINING MESH WAS REMOVED FROM THE CAVITY VIA CURETTAGE AND CONFIRMED BY HYSTEROSCOPY. PATIENT DID NOT RECEIVED POST OP MEDICATIONS AND WAS KEPT IN THE POST ANESTHESIA CARE UNIT FOR NORMAL PROCEDURE. NO PROLONGED STAY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25567396 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MYOSURE PROCEDURE SUCCESSFULLY AND THEN MOVED ON TO THE NOVASURE PROCEDURE ON (B)(6) 2026 WHERE IT WAS REPORTED THE CAVITY INTEGRITY ASSESSMENT (CIA) FAILED THREE TIMES. THE PHYSICIAN PERFORMED HYSTEROSCOPY AND NOTED A PERFORATION NEAR THE TUBAL OSTIA BUT THROUGH THE FUNDUS. THE PROCEDURE WAS ABORTED. NO MEDICAL INTERVENTION WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 25534594 ↗
• 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 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN OBSERVED AFTER THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY THAT THE CERVICAL COLLAR DETACHED FROM THE DEVICE AND REMAINED IN THE CERVICAL OS UPON DEVICE REMOVAL. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY PRIOR TO THE ISSUE BEING IDENTIFIED. THE PHYSICIAN REPORTED THAT THE PATIENT WAS SLIGHTLY OVER DILATED UPON ARRIVAL AND THAT THE CERVICAL COLLAR HAD BEEN PRESSED SECURELY AGAINST THE CERVIX DURING THE PROCEDURE WITH NO ISSUES NOTED DURING CAVITY ASSESSMENT. THE DETACHED CERVICAL COLLAR WAS REMOVED USING TENACULUM FORCEPS. NO PATIENT INJURY AND NO MEDICAL INTERVENTION REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460265 ↗
• 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 ↗
• MalfunctionJun 9, 2026Material Disintegration

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2026 AND AFTER THE PROCEDURE WAS COMPLETED THE STAFF EXAMINED THE DEVICE AND NOTICED THAT THE MESH HAD HOLES IN IT. THE PATIENT WAS EXAMINED VIA HYSTEROSCOPY AND THE RIPPED MESH WAS REMOVED. NO PATIENT INJURY WAS REPORTED AND THE PATIENT WAS REPORTED AS DOING WELL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447573 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THE DEVICE HAD BEEN TESTED OUTSIDE THE PATIENT TO CONFIRM FUNCTIONALITY AND THAT WHILE PERFORMING THE SEATING PROCEDURE THE UTERINE LENGTH WAS 4.5 AND THE CERVICAL LENGTH WAS 3.5 , INITIALLY THE PHYSICIAN COULD NOT DEPLOY PAST 1 CM IN WIDTH AND REMOVED THE DEVICE TO ATTEMPT A SECOND TIME. THEY ENCOUNTERED THE SAME ISSUE AND LATER WAS ABLE TO DEPLOY AT 4.8 CM. WHEN PULLING THE DEVICE BACK BY 0.1 CM THE DEVICE WOULD NOT REDUCE, THE PHYSICIAN WAS NOT COMFORTABLE PROCEEDING AS SHE WAS CONCERNED WITH A PERFORATION. PROCEDURE WAS ABORTED. NO FULL UTERINE PERFORATION WAS REPORTED BUT A SMALL SCRAPE WAS NOTED ON THE UTERINE WALL AND SURGICEL WAS ADMINISTERED AND THE PATIENT TRANSFERRED TO THE POST ANESTHESIA CARE UNIT.

  Patient problems: Laceration(s)

  MAUDE report 25137462 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THERE WAS A ARRAY POSITION ERROR NOTED. IT WAS REPORTED THAT UTERINE SOUNDED TO 7 CM AND THE CAVITY LENGTH MEASUREMENT WAS JUST SHORT OF 4 CM WHICH WAS NOTED TO BE A CONTRAINDICATION. THE PHYSICIAN CHOSE TO PROCEED TO SEAT THE ARRAY BUT THE DIAL REMAINED IN THE RED ZONE. THE ARRAY WAS DEPLOYED EXTERNAL TO THE CAVITY WITH NO ISSUE AND THE DIAL READ OVER 4 CM AND THE ARRAY LIGHT EXTINGUISHED. THE PHYSICIAN DECIDED TO REDILATE THE CERVIX AND THE INTERNAL OS WAS PINCHING DOWN ON THE LOWER SEGMENT OF THE ARRAY. THE ARRAY WAS REINSERTED AFTER DILATION TO A WIDTH OF 2.7 CM. THE PHYSICIAN PROCEEDED WITH THE ABLATION ONCE THE ARRAY LIGHT EXTINGUISHED. THE ABLATION WAS COMPLETED. AN INJURY/ABLATION WAS NOTED TO THE INTERNAL CERVICAL OS. NO POST OPERATIVE TREATMENT WAS PROVIDED TO THE PATIENT. THE PATIENT WAS SENT HOME AFTER THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25086623 ↗
• 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 ↗

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