NovaSure V5 (REF NSV5US-001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 15420045514294), received between Sep 2, 2021 and Jun 17, 2026 — classified as 29 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (14 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 60 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THAT POST THE PROCEDURE GOLD MESH ON THE ARRAY WAS TORN. THE PHYSICIAN THEN PERFORMED HYSTEROSCOPY AND THERE WAS NOTHING FOUND INSIDE THE PATIENT UTERUS. NO ADDITIONAL MEDICATION WAS NEEDED. THE PATIENT IS CURRENTLY STABLE AND THE PATIENT HAS A SCHEDULED ULTRASOUND TO ENSURE THERE ARE NO REMAINING MESH FRAGMENTS OF THE ARRAY IN THE UTERUS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461316 ↗
• MalfunctionJan 7, 2026Material Deformation

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2025, NO ISSUES FOUND DURING THE PROCEDURE AND THE PATIENT RECEIVED A HYSTEROSCOPY, DILATION AND CURETTAGE, ENDOMETRIAL ABLATION AND A LAPAROSCOPIC TUBAL LIGATION. PHYSICIAN REPORTED THAT AFTER REMOVING THE DEVICE FROM THE PATIENT THE SHEATH WAS CRUMPLED UPON REMOVAL. NO ISSUES WITH CLOSING THE HANDLES, RETRACTION OF THE SHEATH AND REMOVAL OF THE DEVICE WAS REPORTED. NO INJURY TO THE PATIENT REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990563 ↗
• MalfunctionJan 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE NOVASURE DEVICE FELT STICKY WHEN TESTING INSIDE THE UTERUS. THE PHYSICIAN STARTED THE ABLATION WITH THE DEVICE AND AFTER USE NOTED THAT THE MESH WAS RIPPED. ALSO, THE DEPLOYED ARRAY WOULD NOT RETRACT FULLY AFTER THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976516 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NOVASURE PROCEDURE ON (B)(6) 2025, WAS COMPLETED UNSUCCESSFULLY. THE PHYSICIAN THEN VISUALIZED THE CAVITY WITH THE HYSTEROSCOPE TO CONFIRM ABLATION WHEN THE PATIENT EXPERIENCED BRADYCARDIA FOLLOWED BY A CARDIAC ARREST. THE PATIENT WAS RESUSCITATED WITH CHEST COMPRESSIONS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 23976463 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON AN UNKNOWN DATE, THAT THE CERVICAL SEAL DETACHED FROM THE DEVICE AND STAYED IN THE PATIENT AFTER THE ABLATION. THE SEAL WAS OBSERVED WHEN RETURNING TO THE PATIENT CAVITY FOR INSPECTION. THE SEAL WAS RETRIEVED AND THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23839027 ↗
• InjuryDec 12, 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, THE PHYSICIAN INITIALLY REPORTED THAT HE WAS EXPERIENCING DIFFICULTIES OPENING THE ARRAY PAST THE 2.5 CM CHECK MARK IN THE CAVITY. INITIALLY PHYSICIAN PERFORMED A HYSTEROSCOPY AND THE CAVITY WAS PERFECT, THEN AFTER ATTEMPTING TO DEPLOY THE ARRAY, PERFORMED ANOTHER HYSTEROSCOPY AND DISCOVERED A UTERINE PERFORATION THAT WAS NOT PRESENT DURING THE INITIAL HYSTEROSCOPY. THE PHYSICIAN ABORTED THE PROCEDURE AND WILL BRING THE PATIENT BACK IN A FEW MONTHS TO PERFORM THE PROCEDURE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23790347 ↗
• MalfunctionNov 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE NOVASURE PROCEDURE ON (B)(6) 2025, THE DEVICE GAVE OUT AN ARRAY POSITION ERROR ABOUT 15 SECONDS INTO THE PROCEDURE. THE WIDTH WAS ABOUT 3.2 CM. THE DEVICE WAS THEN REMOVED TO FIND THAT THE ARRAY LOOKED BENT. THEY DID NOT ENCOUNTER ANY ISSUES WITH THE ARRAY BEFORE SEATING THE DEVICE OR WHILE SEATING THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569863 ↗
• MalfunctionOct 15, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ON (B)(6) 2025, DURING A NOVASURE PROCEDURE, THE DEVICE WORKED SUCCESSFULLY AND WHEN THE PHYSICIAN REMOVED THE DEVICE, TEARS IN THE MESH WERE NOTED. THE PHYSICIAN WENT BACK WITH A SCOPE, AND IT LOOKED GOOD. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289891 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A NOVASURE PROCEDURE, THE PHYSICIAN INSERTED THE DEVICE AND OPENED THE ARRAY. THE PHYSICIAN THEN PERFORMED THE CAVITY INTEGRITY ASSESSMENT TEST AND THE TEST PASSED AND THE ABLATION BEGAN. ABOUT 3-4 SECONDS INTO THE ABLATION, THE ABLATION STOPPED AND DISPLAYED A CAVITY ASSESSMENT FAILURE. THE PHYSICIAN THEN REMOVED THE DEVICE AND REINSERTED THE HYSTEROSCOPE TO CONFIRM THERE WAS A PERFORATION. THE PHYSICIAN THEN PERFORMED LAPAROSCOPY TO TREAT THE PERFORATION AND VERIFY IF THERE ARE ANY ADDITIONAL THERMAL INJURY OUTSIDE THE UTERUS. IT WAS THEN CONFIRMED THAT THERE IS A THERMAL INJURY TO THE SIGMOID COLON AND FALLOPIAN TUBE. PATIENT WAS REPORTED STABLE AND A DRAIN HAD BEEN PLACED OVER UTERUS AND COLON. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bowel Burn; Burn(s); Uterine Perforation

  MAUDE report 23289784 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, POST THE NOVASURE PROCEDURE, LAPAROSCOPY REVEALED A UTERINE PERFORATION WITH SECONDARY THERMAL TRAUMA TO THE MESORECTAL AREA. THERE WAS NO MEDICAL INTERVENTION PROVIDED, AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s); Uterine Perforation

  MAUDE report 23008166 ↗
• MalfunctionAug 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A NOVASURE PROCEDURE THE PHYSICIAN REPORTED THAT AFTER THE ABLATION, PART OF THE MESH WAS FOUND TORN AFTER REMOVING IT FROM THE PATIENT. PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY, PHYSICIAN REINSERTED HYSTEROSCOPE AND REMOVED A SMALL PIECE OF THICK TISSUE FROM THE UTERUS TO SENT TO INQUIRY IF PART OF TISSUE OR PORTION OF NOVASURE. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720302 ↗
• InjuryAug 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT THE CAVITY INITIAL ASSESSMENT WAS FAILING AND PERFORMED A HYSTEROSCOPY WHICH REVEALED A UTERINE PERFORATION AT THE FUNDUS. THE PHYSICIAN BELIEVED THAT THIS OCCURRED WHILE SEATING THE DEVICE. PROCEDURE AT THIS TIME WAS ABORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 22717411 ↗
• MalfunctionAug 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, AFTER A NOVASURE PROCEDURE THE PHYSICIAN EXAMINED THE HANDPIECE AND OBSERVED THAT THE SHEATH AND THE TIP OF THE DEVICE HAD MELTED. THE PHYSICIAN CONFIRMED THAT NO HARM TO THE PATIENT HAD BEEN REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708041 ↗
• InjuryJul 15, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT AFTER SUCCESSFULLY COMPLETING THE ABLATION, THE PHYSICIAN REPORTED HAVING DIFFICULTY REMOVING THE ARRAY AND THAT IT SEEMED STUCK. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRACT THE ARRAY AND REMOVE THE DEVICE FROM THE PATIENT. THEY CHECKED THE ARRAY AFTER REMOVING IT FROM THE PATIENT AND OBSERVED A HOLE IN THE ARRAY. THE SHEATH OF THE DEVICE APPEARED SLIGHTLY CRUMPLED. A HYSTEROSCOPY WAS PERFORMED AND SOME MATERIAL WAS FOUND LEFT IN THE UTERUS. THE PHYSICIAN REMOVED 2 PIECES OF MATERIAL FROM THE UTERUS AND NOTED THAT THERE SEEMED TO BE SMALL PIECES/FLAKES LEFT BEHIND THAT COULD NOT BE REMOVED. A MYOSURE PROCEDURE WAS PERFORMED PRIOR TO THE NOVASURE PROCEDURE IN THE SAME VISIT. NO ANATOMICAL OR STRUCTURAL ABNORMALITIES WERE OBSERVED. NO FURTHER INTERVENTION HAS BEEN PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22510183 ↗
• InjuryJun 25, 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, THE PHYSICIAN WAS NOT ABLE TO PASS INITIAL CAVITY INTEGRITY ASSESSMENT. CHECKED THE CAVITY WITH A HYSTEROSCOPE AND NOTHING LOOKED IRREGULAR. EXCHANGED THE DEVICE FOR A NEW ONE AND WAS STILL UNABLE TO PASS THE CAVITY INITIAL ASSESSMENT. THEY LOOKED AT THE CAVITY A SECOND TIME AND NOTICED A UTERINE PERFORATION FOR WHICH AT THIS POINT ABORTED THE PROCEDURE. PATIENT WAS DISCHARGED AND WAS DOING GREAT AND STABLE. THE PROVIDED NOTIFIED THAT THE PATIENT WILL BE SCHEDULED FOR A COMPLETE HYSTERECTOMY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 22328489 ↗
• InjuryJun 25, 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, THE PHYSICIAN WAS NOT ABLE TO PASS INITIAL CAVITY INTEGRITY ASSESSMENT. CHECKED THE CAVITY WITH A HYSTEROSCOPE AND NOTHING LOOKED IRREGULAR. EXCHANGED THE DEVICE FOR A NEW ONE AND WAS STILL UNABLE TO PASS THE CAVITY INITIAL ASSESSMENT. THEY LOOKED AT THE CAVITY A SECOND TIME AND NOTICED A UTERINE PERFORATION FOR WHICH AT THIS POINT ABORTED THE PROCEDURE. PATIENT WAS DISCHARGED AND WAS DOING GREAT AND STABLE. THE PROVIDED NOTIFIED THAT THE PATIENT WILL BE SCHEDULED FOR A COMPLETE HYSTERECTOMY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 22328258 ↗
• MalfunctionJun 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A NOVASURE PROCEDURE, THE PROCEDURE WAS STOPPED AND THE CERVICAL COLLAR CAME OFF. PHYSICIAN OPENED A SECOND DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY. WHEN THE CERVICAL SEAL WAS DETACHED, IT WAS INSIDE THE VAGINAL CAVITY AND WAS REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171553 ↗
• MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON AN UNKNOWN DATE, THE PHYSICIAN REPORTED THAT THE CERVICAL COLLAR CAME OFF AND BECAME STUCK TO THE PATIENT. THE DEVICE WAS ABLE TO BE REMOVED MANUALLY AND NO MEDICAL INTERVENTION REPORTED AND NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22159783 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT EVERYTHING WENT WELL WITH THE ABLATION BUT WHEN THEY WENT TO RETRACT THE DEVICE THE CERVICAL SEAL STAYED IN THE CERVIX. PHYSICIAN WAS ABLE TO GET THE CERVICAL SEAL AND WAS ABLE TO REMOVE IT WITHOUT ANY COMPLICATIONS OR PATIENT IMPACT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141538 ↗
• InjuryApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, THE CAVITY INTEGRITY ASSESSMENT TEST FAILED, AND IT WAS NOTED THE CERVICAL COLLAR WAS DISLODGED FROM THE HANDPIECE INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED AND A RESECTOSCOPE WAS USED TO RETRIEVE THE COLLAR FROM THE PATIENT. A HYSTEROSCOPE WAS USED TO CHECK THE CAVITY AFTER REMOVAL AND NO INJURY WAS REPORTED. THE PATIENT WAS SENT HOME WITHOUT ANY COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21741066 ↗
• MalfunctionMar 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER COMPLETING A NOVASURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT CAVITY AND NOTICED THERE WAS A SMALL HOLE IN THE MESH. NO PATIENT INJURY WAS REPORTED AND NO ADDITIONAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721743 ↗
• InjuryMar 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2025, DURING THE SEATING OF THE DEVICE THE SURGEON FELT A PERFORATION OCCUR. THE DEVICE WAS REMOVED AND HYSTEROSCOPY PERFORMED, AND THE PERFORATION WAS CONFIRMED. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT WAS BEING MONITORED.

  Patient problems: Uterine Perforation

  MAUDE report 21721560 ↗

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