NovaSure NS2000USRecalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 15420045501140), received between Dec 16, 2016 and Jan 8, 2024 — classified as 53 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 77 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) A NOVASURE PROCEDURE WAS PERFORMED AND AFTER 22 SECONDS OF ABLATION, A CHECK ARRAY ERROR WAS RECEIVED. THE DOCTOR REMOVED THE ARRAY FROM THE PATIENT TO CHECK THE ARRAY AND DID NOT SEE ANY OBVIOUS DAMAGE TO THE ARRAY. THE DEVICE WAS CHECKED BEFORE THE PROCEDURE AND NO MALFUNCTION WAS OBSERVED. THE DOCTOR RESEATED THE DEVICE AND RESTARTED THE ABLATION. THE ABLATION CONTINUED FOR ANOTHER 4 SECONDS BEFORE RECEIVING ANOTHER CHECK ARRAY ERROR. THE DOCTOR CHOSE TO OPEN A SECOND DEVICE. A NOVASURE CLASSIC DEVICE WAS OPENED TO CONTINUE THE PROCEDURE. THE ARRAY WAS CHECKED PRIOR TO DEPLOYING IN THE CAVITY WITH NO DAMAGE OBSERVED. THE CAVITY ASSESSMENT FAILED AND THE DOCTOR ATTEMPTED TO IMPROVE THE CERVICAL SEAL AND FAILED AGAIN. THE DOCTOR REMOVED THE DEVICE TO PERFORM A REPEAT HYSTEROSCOPY AND DISCOVERED A PERFORATION. THE PROCEDURE WAS ABORTED AFTER THE PERFORATION WAS OBSERVED AND LAPAROSCOPY WAS PERFORMED TO CONFIRM THAT THERE WAS NO DAMAGE TO THE SURROUNDING AREA DUE TO THE PERFORATION OR ABLATION FROM THE FIRST DEVICE. AFTER THE PROCEDURE, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH CHEST AND ABDOMINAL PAIN. THE PATIENT HAD CT SCANNING AND VARIOU

  Patient problems: Abdominal Pain; Bowel Burn; Uterine Perforation

  MAUDE report 18468658 ↗
• MalfunctionOct 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2022, THE CUSTOMER STATED THAT THE SHEATH WOULD NOT RETRACT AND COVER THE ARRAY AND THEY WERE ABLE TO REMOVE IT FROM THE PATIENT AND COMPLETE THE PROCEDURE. NO HARM OR INJURY REPORTED. LATER DURING THE PRODUCT INVESTIGATION ON (B)(6) 2022 IT WAS DETERMINED THAT THE SHEATH WAS CRUMPLED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581316 ↗
• InjuryMay 12, 2022Adverse 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) 2022, THE PHYSICIAN WHILE ATTEMPTING TO SEAT THE DEVICE THE PHYSICIAN PERFORATED THE CAVITY OF THE PATIENT´S FUNDUS. THE PATIENT HAD A PRIOR LAPAROSCOPIC SALPINGECTOMY PRIOR TO THIS PROCEDURE, SO THE PHYSICIAN USED THIS ACCESS TO TREAT THE EXCESS BLEEDING AND COAGULATED THE PERFORATION AT THE FUNDUS. THE PATIENT WAS REPORTED STABLE AND IN GOOD CONDITION AFTER THE PROCEDURE. THE NOVASURE PROCEDURE WAS ABORTED DUE TO THE PERFORATION.

  Patient problems: Uterine Perforation

  MAUDE report 14378963 ↗
• MalfunctionMay 9, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE (B)(6) AND THAT THE PROCEDURE WENT WELL BUT AFTER THE PROCEDURE THE MD OBSERVED A PIECE OF THE ARRAY INSIDE THE UTERUS AND REMOVED IT. THE DEVICE WAS EXAMINED AND IT APPEARS THE METAL CAME FROM IT. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS RETURNED AND ANALIZED. VISUAL INSPECTION WAS PERFORMED AND THE DEVICE APPEARED TO REATIN AN OVERALL ACCEPTABLE INTEGRITY INCLUIDING THE SHEATH. NO MISSING PARTS OR MISSING COMPONENTES WERE DETECTED. A FUNCTIONAL TEST WAS PERFORMED INCLUDING CIA, EPA TEST AND ABLATION AND THE DEVICE PERFORMED AS EXPECTED. HENCE THE COMPLAINT CANNOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341586 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A NOVASURE PROCEDURE THE PHYSICIAN WAS HAVING ISSUES WHILE SEATING THE NOVASURE AND PERFORMED A HYSTEROSCOPY AND OBSERVED A UTERINE PERFORATION. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS DOING FINE AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Uterine Perforation

  MAUDE report 13775624 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A NOVASURE PROCEDURE THE PHYSICIAN WAS HAVING ISSUES WHILE SEATING THE NOVASURE AND PERFORMED A HYSTEROSCOPY AND OBSERVED A UTERINE PERFORATION. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS DOING FINE AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Uterine Perforation

  MAUDE report 13775623 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A NOVASURE PROCEDURE THE PHYSICIAN WAS HAVING ISSUES WHILE SEATING THE NOVASURE AND PERFORMED A HYSTEROSCOPY AND OBSERVED A UTERINE PERFORATION. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS DOING FINE AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Uterine Perforation

  MAUDE report 13775619 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 , DURING A NOVASURE PROCEDURE, AN UTERINE PERFORATION WAS OBSERVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 13774876 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A NOVASURE PROCEDURE, AN UTERINE PERFORATION WAS OBSERVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 13774875 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 , DURING A NOVASURE PROCEDURE , AN UTERINE PERFORATION WAS OBSERVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 13774874 ↗
• InjuryNov 23, 2021Adverse 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) 2021 , IN WHICH 2 DEVICES WERE USED , THE FIRST DEVICE FAILED THE CAVITY INITIAL ASSESSMENT AND THEN USED A SECOND DEVICE WHICH COULD NOT DEPLOY INSIDE THE UTERINE CAVITY , AT THIS POINT THE PHYSICIAN OBSERVED A UTERINE PERFORATION AND DECIDED TO ABORT THE PROCEDURE. THE PATIENT WAS STABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 12864318 ↗
• InjuryNov 23, 2021Adverse 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) 2021 , IN WHICH 2 DEVICES WERE USED , THE FIRST DEVICE FAILED THE CAVITY INITIAL ASSESSMENT AND THEN USED A SECOND DEVICE WHICH COULD NOT DEPLOY INSIDE THE UTERINE CAVITY , AT THIS POINT THE PHYSICIAN OBSERVED A UTERINE PERFORATION AND DECIDED TO ABORT THE PROCEDURE. THE PATIENT WAS STABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 12864310 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AUGUST 2ND DURING A NOVASURE PROCEDURE, WHEN THE PHYSICIAN WAS PERFORMING THE CAVITY INITIAL ASSESSMENT CHECK, THE TEST FAILED, ANOTHER NOVASURE DEVICE WAS USED AND STILL THE CAVITY INITIAL ASSESSMENT FAILED , FOR WHICH THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND OBSERVED A UTERINE PERFORATION. THE PROCEDURE WAS ABORTED. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Uterine Perforation

  MAUDE report 12492554 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AUGUST 2ND DURING A NOVASURE PROCEDURE, WHEN THE PHYSICIAN WAS PERFORMING THE CAVITY INITIAL ASSESSMENT CHECK, THE TEST FAILED, ANOTHER NOVASURE DEVICE WAS USED AND STILL THE CAVITY INITIAL ASSESSMENT FAILED , FOR WHICH THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND OBSERVED A UTERINE PERFORATION. THE PROCEDURE WAS ABORTED. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Uterine Perforation

  MAUDE report 12492538 ↗
• MalfunctionJul 1, 2021Defective Device

  DR. (B)(6) PERFORMING NOVASURE ABLATION. ABLATION WOULD NOT COMPLETE CYCLE. SEVERAL ATTEMPTS WERE MADE TO CORRECT THE ERROR MESSAGES THAT KEPT OCCURRING ON THE GENERATOR. A SECOND NOVASURE DEVICE WAS OPENED AND USED AND COMPLETED THE CYCLE WITHOUT INCIDENT. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107281 ↗
• MalfunctionMay 6, 2021Deformation Due to Compressive Stress; Insufficient Device Problem Information; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6), WHILE PERFORMING A NOVASURE PROCEDURE, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT AND THE PHYSICIAN HAD TO USE FORCEPS TO REMOVE IT. NO PATIENT HARM WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787792 ↗
• MalfunctionApr 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON APRIL 16TH DURING A NOVASURE PROCEDURE, AFTER THE ABLATION, THE PHYSICIAN NOTICED THAT THE ARRAY WAS TORN AND PERFORMED AN HYSTEROSCOPY AND OBSERVED AN INCOMPLETE ABLATION. NO HARM TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757546 ↗
• MalfunctionMar 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6), AFTER A NOVASURE PROCEDURE, THE DEVICE WAS FIXED INSIDE THE UTERINE CAVITY AND THE PHYSICIAN HAD TO USE RING FORCEPS TO REMOVE THE DEVICE. UPON INSPECTION THE SHEATH WAS DEFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11589017 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON FEBRUARY 19TH, DURING A NOVASURE PROCEDURE A UTERINE PERFORATION WAS OBSERVED. THE PROCEDURE WAS ABORTED AND THE PHYSICIAN SCHEDULED A HYSTERECTOMY.

  Patient problems: Uterine Perforation

  MAUDE report 11406473 ↗
• MalfunctionJan 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020 AFTER A NOVASURE PROCEDURE THE DEVICE APPEARED FRAYED AND BURNED AT THE END, AFTER RECEIVING THE PRODUCT AND INSPECTION ON JANUARY 12TH BY INVESTIGATORS, THE EXTERNAL SHEATH WAS OBSERVED AS CRUMPLED. NO INJURY TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209630 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON DECEMBER 4TH, A PHYSICIAN PERFORMED A MYOSURE PROCEDURE FIRST ON A PATIENT, THEN ATTEMPTED TO PERFORM A UTERINE ABLATION USING A NOVASURE DEVICE, BUT THE CAVITY INITIAL ASSESSMENT ALARM WENT OFF ALERTING OF LOSS OF PRESSURE, HE CHANGED THE DISPOSABLE AN OBTAINED THE SAME ALARM PROMPTING THE PHYSICIAN TO PERFORM A HYSTEROSCOPY OBSERVING A PERFORATION ON THE UTERUS. HE ABORTED THE NOVASURE PROCEDURE WITHOUT MAKING ANY ABLATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 11099639 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON DECEMBER 4TH, A PHYSICIAN PERFORMED A MYOSURE PROCEDURE FIRST ON A PATIENT, THEN ATTEMPTED TO PERFORM A UTERINE ABLATION USING A NOVASURE DEVICE, BUT THE CAVITY INITIAL ASSESSMENT ALARM WENT OFF ALERTING OF LOSS OF PRESSURE, HE CHANGED THE DISPOSABLE AN OBTAINED THE SAME ALARM PROMPTING THE PHYSICIAN TO PERFORM A HYSTEROSCOPY OBSERVING A PERFORATION ON THE UTERUS. HE ABORTED THE NOVASURE PROCEDURE WITHOUT MAKING ANY ABLATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 11099636 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I WAS REPORTED ON (B)(6) 2020 THAT A PHYSICIAN PERFORMED A NOVASURE PROCEDURE ON THE PATIENT, PRIOR TO THE PROCEDURE A HYSTEROSCOPY WAS PERFORMED AND THERE WERE NO AREAS OF INJURY. AFTER THE PROCEDURE PHYSICIAN STATED THAT LAPAROSCOPY WAS PERFORMED AND A FUNDAL PERFORATION WAS SEEN AT FUNDUS. NO BOWEL INJURY WAS VISUALIZED. THE PERFORATION WAS NOT TREATED AND THAT THERE ARE CURRENTLY NO ADDITIONAL DETAILS AVAILABLE ABOUT CURRENT PATIENT STATUS.

  Patient problems: Uterine Perforation

  MAUDE report 10823294 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 09, 2020 HOLOGIC WAS NOTIFIED OF AN EVENT INVOLVING THE NOVASURE DEVICE WHICH OCCURRED ON (B)(6) 2020. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO COMPLETE THE NOVASURE PROCEDURE DUE TO THE DEVICE FAILING TO OPEN COMPLETELY. THE PROCEDURE WAS ABORTED AND A SECOND DEVICE WAS NOT OPENED TO ATTEMPT TO COMPLETE THE PROCEDURE. THE PATIENT WAS SENT TO THE ER DUE FOR HEAVY BLEEDING AND CT. THE PATIENT WAS LATER SENT HOME FROM ER STABLE WITH IMPROVED CONDITIONS. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10602462 ↗
• InjurySep 22, 2020Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, "THE DEVICE WAS FLASHING CHECK ARRAY' AND WE COULDN'T GET PAST IT. WE PULLED A SECOND DEVICE AND THAT ONE WORKED JUST FINE. WE WERE NOT ABLE TO COMPLETE THE PROCEDURE THOUGH DUE TO UTERINE PERFORATION." NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 10569205 ↗

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