NovaSure V5 (REF NSV5KITUS-001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 15420045514300), received between Dec 23, 2021 and Aug 12, 2026 — classified as 2 deaths, 43 injuries, 47 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A NOVASURE PROCEDURE ON (B)(6) 2026, A PIECE OF METAL WAS SEEN IN A MENSTRUAL PAD. SINCE THE PROCEDURE THE PATIENT IS EXPERIENCING DYSFUNCTION UTERINE BLEEDING WHICH WAS DESCRIBED TO BE INTERMITTENT, AND THE PATIENT WAS BLEEDING EVERY TWO WEEKS FOR TWO WEEKS. PER A FOLLOW UP VISIT IN JANUARY, THERE WAS NO SIGNS OF INFECTION AND TENDERNESS. THE PATIENT THEN FOUND A PIECE OF METAL IN THE MENSTRUAL PAD WHICH APPEARED TO BE A THIN PIECE OF WIRE 3MM IN LENGTH. THE PHYSICIAN THEN PERFORMED AN ULTRASOUND AND APPEARED TO BE NORMAL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24985705 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026 THAT THE FIRST DEVICE PASSED CAVITY INTEGRITY ASSESSMENT (CIA) TEST. ABOUT 50 SECONDS INTO THE PROCEDURE, A VACUUM ALARM WAS RECEIVED. UPON CHECKING TUBING AND PRESSING VACUUM RELIEF VALVE, THE ABLATION WAS AGAIN AND IN ABOUT 5 SECONDS RECEIVED A VACUUM ALARM. THE ARRAY WAS REMOVED AND A SECOND DEVICE WAS INSERTED INTO THE CAVITY AND WOULD NOT PASS CAVITY INTEGRITY ASSESSMENT TEST. THE PHYSICIAN WENT IN WITH THE HYSTEROSCOPE AND FOUND A SMALL PERFORATION ON THE FUNDUS. THE PHYSICIAN ABORTED THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24947323 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026 THAT THE FIRST DEVICE PASSED CAVITY INTEGRITY ASSESSMENT (CIA) TEST. ABOUT 50 SECONDS INTO THE PROCEDURE, A VACUUM ALARM WAS RECEIVED. UPON CHECKING TUBING AND PRESSING VACUUM RELIEF VALVE, THE ABLATION WAS AGAIN AND IN ABOUT 5 SECONDS RECEIVED A VACUUM ALARM. THE ARRAY WAS REMOVED AND A SECOND DEVICE WAS INSERTED INTO THE CAVITY AND WOULD NOT PASS CIA TEST. THE PHYSICIAN WENT IN WITH THE HYSTEROSCOPE AND FOUND A SMALL PERFORATION ON THE FUNDUS. THE PHYSICIAN ABORTED THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24947240 ↗
• MalfunctionApr 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THERE WAS A CRACKED WIDTH DIAL. NO PATIENT IMPACT WAS REPORTED ANT THEY WERE ABLE TO GET THROUGH THE PROCEDURE WITH THE DEVICE. NO DAMAGE TO THE OUTER BOX OR INNER PACKAGING. LATER THE DEVICE WAS RETURNED FOR INVESTIGATION AND THE CERVICAL SEAL WAS MISSING. HOLOGIC CONTACTED THE CUSTOMER FOR ADDITIONAL INFORMATION AND THE CUSTOMER NOTIFIED HOLOGIC ON (B)(6) 2026, THAT THE CERVICAL SEAL HAD COME OFF DURING THE PROCEDURE. THE DEVICE WAS INVESTIGATED AND THE VISUAL INSPECTION REVEALED THAT THE CERVICAL SEAL WAS MISSING FROM THE DEVICE AND THE FLEXURES WERE BENT. FUNCTIONAL TESTING COULD NOT BE CONDUCTED DUE TO THE DAMAGE ON THE DEVICE AND THE ISSUE WAS CONFIRMED DURING THE VISUAL INSPECTION. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821637 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE AND SONATA CONCOMITANT PROCEDURE ON (B)(6) 2026. PATIENT RECEIVED ADDITIONALLY DILATION AND CURETTAGE. THE PATIENT WAS DISCHARGED THE SAME DAY AND WAS LATER ADMITTED TO THE HOSPITAL THE NEXT DAY WITH SIGNS OF NECROSING FIBROID AND ENDOMETRITIS. PATIENT HAS BEEN IN THE HOSPITAL FOR 3 DAYS AND RECEIVING ANTIBIOTICS. THERE WERE NO SIGNS OF BOWEL NOR BLADDER INJURY. THE DIAGNOSIS OF NECROSING FIBROID AND ENDOMETRITIS CONFIRMED. A SINGLE FIBROID TREATED WITH SONATA WITH MULTIPLE OVERLAPPING ABLATIONS WITHOUT COMPLICATION. ADDITIONAL INFORMATION RECEIVED PHYSICIAN REPORTED THAT PATIENT MET THE CRITERION FOR SEPSIS. PATIENT IS IMPROVING AND REPORTED THAT PATIENT DID NOT RECEIVE PREOPERATORY ANTIBIOTICS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Necrosis; Sepsis

  MAUDE report 24817046 ↗
• MalfunctionMar 25, 2026Material Deformation

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE PHYSICIAN INSPECTED THE ARRAY OUTSIDE THE PATIENT, INSERTED IT INTO THE CAVITY AND THE ARRAY WOULD NOT OPEN. THE PHYSICIAN PULLED BACK AND RESEATED. 25 SECONDS INTO THE ABLATION, THE ARRAY WAS PULLED OUT OF THE PATIENT AND NOTED THAT THE END OF THE ARRAY WAS ASYMMETRICAL IN SHAPE. THERE WAS NO MESH MISSING. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689080 ↗
• MalfunctionMar 11, 2026Material Puncture/Hole

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THAT THERE WAS A VALVE PROBLEM AND AN ERROR MESSAGE APPEARED SEVERAL TIMES WITHOUT BEING ABLE TO COMPLETE THE INTERVENTION. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. UPON INVESTIGATION ON (B)(6) 2026. A HOLE IN THE ARRAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571487 ↗
• MalfunctionMar 10, 2026Material Puncture/Hole

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE PROCEDURE WAS COMPLETED AND UPON REMOVING THE ARRAY, IT WAS NOTED THE ARRAY WAS TOWN AND WAS MISSING PIECES. THE PHYSICIAN THEN WENT INTO THE CAVITY WITH THE HYSTEROSCOPE AND REMOVED THE PIECES WITH GRASPERS. THE PHYSICIAN CONFIRMED AN EMPTY CAVITY. THE PHYSICIAN REPORTED THAT THE CAVITY ANATOMY IS NORMAL AND THE ABLATION WAS UNEVENTFUL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561615 ↗
• MalfunctionMar 3, 2026Material Puncture/Hole

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE PHYSICIAN PERFORMED ABLATION AND WHILE REMOVING THE ARRAY, IT WAS NOTED THAT THE ARRAY IS DAMAGED, THERE WAS A HOLE IN THE ARRAY. THE PHYSICIAN THEN INSERTED THE HYSTEROSCOPE INTO THE CAVITY AND DID NOT FIND ANY MESH IN THE CAVITY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501088 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026. THAT THE CERVICAL SEAL DETACHED FROM THE DEVICE AND STAYED INSIDE THE PATIENT. THE CERVICAL SEAL WAS THEN MANUALLY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482579 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE DEVICE WAS INITIALLY SEATED AND THE CAVITY INTEGRITY TEST PASSED. THE ABLATION BEGAN AND THE ABLATION TIME WAS 1 MINUTE AND 8 SECONDS WHEN THE VACUUM ALERT DISPLAYED AND THE ABLATION WAS STOPPED. IT WAS THEN VERIFIED THAT THE TUBING WAS HANGING BELOW THE PATIENT'S LEG. NO LEAK WAS NOTED AT THE CERVIX, NO FLUID WAS OVERFLOWING THE TUBING TO THE DESICCANT, AND THE VACUUM VALVE WAS ACTUATED. THE VACUUM ALERT CONTINUED AND THAT'S WHEN THE PHYSICIAN CHOSE TO TRY ANOTHER DEVICE. AFTER SEATING THE ARRAY ON THE SECOND DEVICE, THE CAVITY ASSESSMENT TEST FAILED AND A HYSTEROSCOPY WAS PERFORMED. A PERFORATION AT THE FUNDUS WAS NOTED AND THE PHYSICIAN THEN PERFORMED A LAPAROSCOPY TO REPAIR AND SUTURE THE PERFORATION, AND THE SURGERY WAS SUCCESSFUL. NO ADDITIONAL INJURY NOTED TO THE SURROUNDING STRUCTURES. THE PATIENT IS WAKING UP FROM SURGERY. NO FURTHER SURGERY OR MEDICATION WAS ADMINISTERED TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Bowel Burn; Fever; Uterine Perforation

  MAUDE report 24429797 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT THE DEVICE WAS INITIALLY SEATED AND THE CAVITY INTEGRITY TEST PASSED. THE ABLATION BEGAN AND THE ABLATION TIME WAS 1 MINUTE AND 8 SECONDS WHEN THE VACUUM ALERT DISPLAYED AND THE ABLATION WAS STOPPED. IT WAS THEN VERIFIED THAT THE TUBING WAS HANGING BELOW THE PATIENT'S LEG. NO LEAK WAS NOTED AT THE CERVIX, NO FLUID WAS OVERFLOWING THE TUBING TO THE DESICCANT, AND THE VACUUM VALVE WAS ACTUATED. THE VACUUM ALERT CONTINUED AND THAT'S WHEN THE PHYSICIAN CHOSE TO TRY ANOTHER DEVICE. AFTER SEATING THE ARRAY ON THE SECOND DEVICE, THE CAVITY ASSESSMENT TEST FAILED AND A HYSTEROSCOPY WAS PERFORMED. A PERFORATION AT THE FUNDUS WAS NOTED AND THE PHYSICIAN THEN PERFORMED A LAPAROSCOPY TO REPAIR AND SUTURE THE PERFORATION, AND THE SURGERY WAS SUCCESSFUL. THE PATIENT IS WAKING UP FROM SURGERY. NO ADDITIONAL INJURY NOTED TO THE SURROUNDING STRUCTURES. NO FURTHER SURGERY OR MEDICATION WAS ADMINISTERED TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Bowel Burn; Fever; Uterine Perforation

  MAUDE report 24429769 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THE PATIENT HAD ¨DIFFERENT¨ ANATOMY AND CALLED A PARTNER AS WELL AS AN ULTRASOUND TECH TO ASSIST. ABLATION WAS COMPLETED AND A HYSTEROSCOPY USING A FLUENT AND OMNI SCOPE WAS PERFORMED PRE AND POST ABLATION WITH NO ISSUES TO NOTE NOR INCREASE IN DEFICIT WITH THE FLUENT MACHINE. PATIENT DID NOT HAD AN ENDOMETRIAL BIOPSY PRIOR PROCEDURE SO THE PHYSICIAN PERFORMED A DILATION AND CURETTAGE IN THE OPERATING ROOM. PATHOLOGY CAME BACK WITH RESULTS AS ACUTE CHRONIC INFLAMMATION. ON (B)(6) THE PATIENT COMPLAINED OF ABDOMINAL PAIN FOR WHICH DIFFERENT MEDICATIONS WERE GIVEN AT THE TIME. ON (B)(6) 2026 THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN AND CONFUSION. LACTATE WAS 6.7 AND BLOOD PRESSURE PER HOSPITAL WAS ¨38/15¨. PATIENT RECEIVED AN EXPLORATORY LAPAROSCOPY AND WHEN THE TROCARS WERE INSERTED PUSS WAS OOZING AND THE ABDOMEN OF THE PATIENT WAS FULL OF PUSS. NO THERMAL INJURY WAS OBSERVED AND A SPOT IN THE CORNUAL AREA WAS OBSERVED TO HAVE FAT PRESSED AGAINST THE UTERUS. PATIENT WAS TOO DELICATE TO PERFORM A HYSTERECTOMY AND WAS INTUBATED AND BROUGHT TO THE ICU ON ANTIBIOT

  Patient problems: Abdominal Pain; Cardiogenic Shock; Sepsis; Septic Shock

  MAUDE report 24348635 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MYOSURE, SONATA AND NOVASURE PROCEDURE ON (B)(6) 2026. POST THE PROCEDURES, THE PATIENT WENT TO THE EMERGENCY A FEW DAYS LATER AFTER THE PROCEDURE DUE TO FEVER. PATIENT IS BACK HOME AND IS DOING WELL. DURING A PEER TO PEER CONSULTATION REQUEST ADDITIONAL INFORMATION WAS RECEIVED FOR THE CASES. IT WAS REPORTED THAT A PATIENT RECEIVED A CONCOMITANT PROCEDURE (NOVASURE, MYOSURE AND SONATA) ON A PATIENT, PHYSICIAN REPORTED THAT THE TREATED FIBROIDS WERE 4 AND 5 CM TYPE 2 MIOMAS POSSIBLE TYPE 1, THAT REQUIRED RESECTION PRIOR TO THE TREATMENT WITH SONATA. THE PATIENT LATER PRESENTED TO THE EMERGENCY ROOM WITH FEVER. PATIENT RECEIVED AN ULTRASOUND AND WAS STARTED ON KEFLEX AND METRONIDAZOLE. THE TREATING PHYSICIAN LATER CHANGED THE MEDICATION TO AUGMENTIN. PATIENT HAD NO OBJECTIVE SIGNS OF INFECTION BUT WAS SPIKING FEVERS IN THE MIDDLE OF THE NIGHT WITHOUT TAKING ANY MEDICATION. PATIENT COMPLAINED OF WATERY DISCHARGE. PHYSICIAN REPORTED THAT THE WATERY DISCHARGED THAT LASTS FOR SEVERAL WEEKS IS NOT UNCOMMON WITH RADIOFREQUENCY ABVLATION FOR SUBMUCOSAL FIBROIDS AND IS USUALLY NOT ASSOCIATED WITH FEVER CHILLS OR ELEVATED WHITE BLOOD COUNT. THE PRES

  Patient problems: Fever

  MAUDE report 24307490 ↗
• MalfunctionJan 27, 2026Material Deformation

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE SHEATH WAS WRINKLED AFTER REMOVING THE DEVICE FROM THE PATIENT. THE PHYSICIAN OBSERVED THE CAVITY VIA HYSTEROSCOPY POST PROCEDURE AND THE ABLATION WAS NORMAL WITH NO FOREIGN MATERIAL OBSERVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192514 ↗
• MalfunctionJan 27, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE PROCEDURE WAS COMPLETED AND THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS REPORTED THAT THERE IS A HOLE IN THE ARRAY. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192389 ↗
• MalfunctionJan 20, 2026Material Puncture/Hole

  IT WAS REPORTED POST THE NOVASURE PROCEDURE ON (B)(6) 2026, A TEAR IN THE ARRAY WAS NOTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS A SMALL DEFECT IN THE TIP OF THE SHEATH. THE PHYSICIAN WENT BACK THROUGH THE HYSTEROSCOPE AND NO PIECES, STRANDS AND THREADS OF THE ARRAY WERE NOTED. THERE WAS NO HARM TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121743 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT THE PATIENT HAD A NOVASURE AND ACESSA PROCEDURE ON (B)(6) 2025, AND PATIENT PRESENTED WITH LOW GRADE FEVER ON (B)(6) 2025. THE PHYSICIAN PERFORMED AN ULTRASOUND AND NOTES AIR AND FLUID FOUND WITHIN THE ONE 4 CM FIBROID THAT HAD 3 ABLATIONS. THE NOVASURE PROCEDURE WAS PERFORMED FIRST FOLLOWED BY THE ACESSA PROCEDURE, NO COMPLICATIONS WERE NOTED WITH EITHER OF THE PROCEDURES. PATIENT IS IN THE HOSPITAL NOW FOR OBSERVATION. PER A CLINICAL DISCUSSION THE PATIENT WAS A 47-YEAR-OLD WHO HAD A ACESSA PROCEDURE HAD A4 TO 5-CENTIMETER TYPE 5 SEB SEROSAL FIBROID TREATED WITH APPROXIMATELY 4 ACTIVATIONS WITH NO CONCERNS IMMEDIATELY PRIOR TO ACCESS OF THE PATIENT HAD A NOVASURE PROCEDURE AGAIN WITH NO OBVIOUS COMPLICATIONS. APPROXIMATELY 10 DAYS LATER THE PATIENT WAS READMITTED WITH PAIN AND CT SCAN SHOWED A 4 BY 6 CENTIMETER ENHANCING FLUID COLLECTION. THE PATIENT IS NOT FEBRILE OR TENDER. AN ULTRASOUND CODE A SIMILAR FLUID COLLECTION HOWEVER, THE RADIOLOGIST WAS UNSURE IF THIS REPRESENTED AN ABSENCE. MRI IS ORDERED BUT NOT COMPLETED YET. THE PHYSICIAN WAS UNCERTAIN IF PROPHYLACTIC ANTIBIOTICS HAD BEEN ADMINISTERED PRIOR TO THE PROCEDURE. THE DISCUSSION WITH THE PHYSICIAN W

  Patient problems: Fever

  MAUDE report 23990532 ↗

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