MyoSure Tissue Removal Device 30-401LITERecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 15420045505070), received between Jan 26, 2018 and Sep 24, 2026 — classified as 1 death, 27 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (11 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 24, 2026Insufficient Device Problem Information

  It was reported that during a MyoSure Lite and Omni procedure on (b)(6) 2026, the physician reported that after a few minutes of using the MyoSure Lite a silver residue was observed in the Uterine Cavity. After the procedure was completed the mesh was sent to pathology but nothing could be see with the naked eye. It was reported that all the residue was flushed from the cavity and that no harm to the patient occurred. No medical intervention required. Good faith efforts were completed and no additional information was received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884142 ↗
• MalfunctionSep 21, 2026Material Disintegration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846177 ↗
• MalfunctionSep 10, 2026Material Disintegration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722859 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50521426 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166023 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165962 ↗
• 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 25625941 ↗
• MalfunctionJun 17, 2026Material Disintegration

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2026, DURING RESECTING TISSUE FROM CAVITY, SOME BLACK PIECES OR SPECS WERE FOUND IN THE CAVITY. IT WAS UNSURE IF THEY WERE BLACK SPECS OR BLOOD VESSELS, BUT EVERYTHING WAS RESECTED AND NO MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS SWITCHED AND THE PROCEDURE WAS THEN COMPLETE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534183 ↗
• MalfunctionJun 9, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THE STAFF REPORTED THAT METAL FRAGMENTS WERE OBSERVED IN THE UTERUS. THE PHYSICIAN REMOVED THE MYOSURE FROM THE UTERINE CAVITY AND FLUSHED IT AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449268 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MYOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2026, AND THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2026, COMPLAINING ABOUT ABDOMINAL PAIN. APPROXIMATELY 50 ML OF BLOOD WAS OBSERVED IN THE UTERINE CAVITY, SO THE PATIENT WAS TRANSPORTED TO THE TERTIARY CARE FACILITY BY AMBULANCE. THE TOTAL BLOOD LOSS, PATIENT'S CURRENT CONDITION, AND IF THE BLOOD TRANSFUSION IS ADMINISTERED IS UNKNOWN. DUE TO THE POOR VISIBILITY DURING THE PROCEDURE CAUSED BY BLEEDING, HEMOSTATIC AGENTS WERE PRESCRIBED FOR 4 DAYS POSTOPERATIVELY. THERE WAS NO BLEEDING IMMEDIATELY AFTER SURGERY OR DURING THE FOLLOW UP VISIT THE FOLLOWING DAY. THE PATHOLOGY RESULTS INDICATED AN ADENOMATOUS POLYP WITH A HARD LESION RESEMBLING ADENOMYOSIS. COLOR DOPPLER IMAGING CONFIRMED BLOOD FLOW NEAR THE BASE OF THE POLYP. NO OTHER MEDICAL DEVICES WERE USED IN CONJUNCTION WITH THIS PROCEDURE. THE PATIENT REMAINS HOSPITALIZED AND THE PATIENT'S CONDITION IS BEING MONITORED. ADDITIONAL INFORMATION WAS REPORTED THAT ON (B)(6) THE PATIENT WAS URGENTLY TRANSPORTED TO A TERTIARY CARE FACILITY, BUT SINCE NO TREATMENT WAS REQUIRED AT THE TIME OF ARRIVAL, THEY WERE NOT ADMITTED AND WERE DISCHARGED THE SAME DAY. THEREFORE

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25085026 ↗
• MalfunctionApr 21, 2026Material Disintegration

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THAT THE PHYSICIAN OBSERVED METAL SHAVINGS IN THE CAVITY WHILE PERFORMING RESECTION. THE PHYSICIAN WAS RESECTING ADHESIONS IN THE CAVITY. PHYSICIAN USED SUCTION FROM THE DEVICE TO CLEAR THE SHAVINGS IN THE CAVITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24942472 ↗
• InjuryApr 3, 2026Suction Problem; Failure to Obtain Sample

  IT WAS REPORTED THAT A PATIENT RECEIVED A MYOSURE PROCEDURE ON AN UNKNOWN DATE. THE CUSTOMER REPORTED THAT DURING THE PROCEDURE THE DEVICE WASN´T PULLING FLUID THROUGH THE SHAFT AND THAT THERE WAS A POSSIBILITY OF TISSUE NOT BEING PULLED. ANOTHER DEVICE WAS OPENED THE DEVICE EXPERIENCING THE LOSS OF SUCTION WAS EXCHANGED. HOLOGIC FOLLOWED UP WITH THE CUSTOMER AND IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO PATIENT INJURY REPORTED, NO TISSUE LOST AND NO MEDICAL INTERVENTION REQUIRED. HOWEVER, DURING AN INVESTIGATION ON (B)(6) 2026, WHEN OPENING THE DEVICE IT WAS FOUND THAT INSIDE THE TUBBING TISSUE SAMPLE TISSUE FROM THE PROCEDURE WAS FOUND. THIS SAMPLE IS UNUSABLE FOR PATHOLOGY TESTING THUS IT IS CONSIDERED LOST. ADDITIONAL VISUAL INSPECTION ON THE DEVICE REVEALED THAT THE TUBING HAD BEEN CUT, AND A METAL PIECE WAS FUND INSIDE ONE OF THE SCREWS THAT HOLDS THE HANDLE TOGETHER WHICH IS NOT RELATED TO THE TUBING. A SUCTION TEST COULD NOT BE PERFORMED DUE TO THE CUTTING OF THE TUBE AND A BLOCKAGE WAS OBSERVED RELATED TO THE PATHOLOGY BEING STUCK. THE INNER CANNULA HAD SCRATCHES ON THE INSIDE AND METAL PARTICLES WERE OBSERVED INSIDE THE HANDLE. NO OTHER INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775474 ↗
• MalfunctionFeb 10, 2026Material Fragmentation

  IT WAS REPORTED THAT AFTER A MYOSURE PROCEDURE ON AN UNKNOWN DATE IN LATE 2025, THE PHYSICIAN REPORTED THAT THEY FOUND METAL SHAVINGS INSIDE THE CAVITY POST OPERATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307697 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN WAS PERFORMING THE DIRECT VISUALIZED MYOSURE SAMPLING WITH THE MYOSURE LITE DEVICE. IT WAS FOLLOWED BY THE SECONDARY SAMPLING WITH METAL CURETTE. THE DEVICE WAS DEPLOYED WITHOUT RESISTANCE AND REACHED 4.9 CM IN WIDTH. CAVITY ASSESSMENT FAILED MULTIPLE TIMES AFTER TROUBLESHOOTING. DIAGNOSTIC HYSTEROSCOPY NOTED DEFICIT SPIKING RAPIDLY WITH NO CERVICAL LEAKAGE AND WAS UNABLE TO MAINTAIN DISTENTION. PROCEDURE WAS ABORTED FROM POTENTIAL PERFORATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23957966 ↗
• MalfunctionNov 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN USED THE MYOSURE LITE DEVICE TO RESECT SOME POLYPOID TISSUE AND THE OMNI SCISSORS TO HELP TAKE DOWN SOME SCARRING IN THE PATIENT'S UTERUS. WHEN THE PHYSICIAN WENT BACK IN TO TAKE FINAL PICTURES, A LONG STRAND OF METAL IN THE PATIENT'S CAVITY WAS NOTED. THE PHYSICIAN REMOVED THE SHAVINGS USING THE GRASPERS. THERE WAS NO HARM REPORTED. AN X RAY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23542547 ↗
• MalfunctionOct 31, 2025Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED THAT DURING THE MIDDLE OF MYOSURE PROCEDURE ON (B)(6) 2025 PROCEDURE WHILE CUTTING, THE PHYSICIAN WAS USING THE DEVICE ON SMALL PATHOLOGY AND NOTICED METAL SHAVINGS FLOATING IN THE CAVITY. THE PHYSICIAN THEN REMOVED THE DEVICE AND SCOPE, FLUSHED THE CAVITY, AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE CAVITY WAS COMPLETELY CLEARED AND FLUSHED OF THE MATERIAL BEFORE REPLACING THE DEVICE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438014 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AUGUST 29TH, 2025, THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THERE WAS A BLADDER INJURY, AND UROTHELIAL CELLS WERE IDENTIFIED IN THE MYOSURE SAMPLE BY THE PATHOLOGIST. IT WAS ALSO REPORTED SUBSEQUENT FINDING OF ADENOCARCINOMA. A PERFORATION INTO THE BLADDER DOME WAS NOTED. CYSTOSCOPY WAS PERFORMED AFTER THE MYOSURE PROCEDURE WITH DIATHERMY TO CONTROL BLEEDING. THE PATIENT HAD A HISTORY OF TWO CESAREAN DELIVERIES AND WAS FOUND TO HAVE ENDOMETRIAL THICKENING 13MM POST MENOPAUSE. PATHOLOGY CONFIRMED HIGH GRADE CANCER. THE PATIENT REQUIRED TRANSFER TO THE ICU HOSPITAL AND WAS DISCHARGED AFTER 3 DAYS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cancer; Uterine Perforation

  MAUDE report 22984083 ↗
• MalfunctionAug 29, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED ON (B)(6) 2025 DURING A MYOSURE PROCEDURE THAT THE PHYSICIAN NOTED METAL SHAVINGS IN THE CAVITY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22927466 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025 ON A POST-PARTUM PATIENT, THE PHYSICIAN REPORTED THAT THEY CUT THE BOWEL DUE TO A WEAK UTERUS AND BAD VISIBILITY. THE BOWEL WAS STITCHED AND THE PATIENT WAS DOING FINE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bowel Perforation; Uterine Perforation

  MAUDE report 22328121 ↗
• MalfunctionJun 16, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT DURING A MYOSURE LITE PROCEDURE ON (B)(6) 2025, THE STAFF REPORTED THAT THEY DISCOVERED METAL SHAVINGS IN THE PATIENT. THEY PULLED THE DEVICE AND USED A SECOND ONE TO COMPLETE THE PROCEDURE. METAL FLAKES WERE STUCK TO THE FIBROID AND WERE REMOVED WITH THE SECOND DEVICE. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212275 ↗
• MalfunctionApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN BELIEVED THAT THE BLADE BROKE INSIDE THE PATIENT SINCE THEY WERE UNABLE TO LOCATE IT POST PROCEDURE. CHECKED INSIDE THE PATIENT, PATHOLOGY, DEVICE, SCOPE AND SHEATHS AND TUBING AND X-RAYED THE PATIENT AND DID NOT FIND ANY FRAGMENTS LEFT BEHIND. PATHOLOGY WAS NOT REPORTED AS HARD OR CALCIFIED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741770 ↗
• MalfunctionMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, A GRINDING NOISE WAS HEARD FROM THE MYOSURE DEVICE. THE SURGEON THEN NOTICED ¿SHINY SPECS¿ FLOATING IN THE DISTENDED CAVITY. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE CAVITY WAS FLUSHED WITH SALINE WITH NO FURTHER PIECES SEEN AND THE PROCEDURE WAS DEEMED COMPLETE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21691549 ↗
• MalfunctionMar 18, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT DURING A MYOSURE LITE PROCEDURE ON (B)(6) 2025, SMALL METAL FRAGMENTS/PIECES WERE NOTED FLOATING IN THE UTERINE CAVITY. THE METAL PIECES WERE REMOVED AND NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21635444 ↗
• InjuryDec 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A PHYSICIAN WAS PERFORMING A MYOSURE PROCEDURE, UPON DILATING USING A HAGAR DILATOR THE PHYSICIAN CAUSED A SMALL PERFORATION. PHYSICIAN CHOSE TO CONTINUE WITH THE MYOSURE LITER DEVICE. POST PROCEDURE THE FLUID DEFICIT WAS 2300 ML. PATIENT WAS RETURNED TO THE RECOVERY ROOM BUT BECAME HYPOTENSIVE. AT THIS POINT THE PHYSICIAN PERFORMED A DIAGNOSTIC LAPAROSCOPY AND STATED THAT A UTERINE PERFORATION WAS OBSERVED AT THE CORNUAL REGION WHERE ADHESIONS WERE MOST DENSE. PHYSICIAN PERFORMED A SALPINGO-OOPHORECTOMY AND ADHESIOLYSIS AFTER THE UTERINE PERFORATION LED TO INTRAABDOMINAL HEMORRHAGE. PATIENT LOST 1.5-2 L OF BLOOD. PATIENT RECEIVED 1 UNIT OF BLOOD IN THE OPERATING ROOM AND REMAINED VITALLY STABLE. PATIENT WAS MONITORED OVERNIGHT AND SENT HOME. PATIENT IS RECOVERING FROM THE PROCEDURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 21019317 ↗
• InjuryNov 15, 2024Material Disintegration; Adverse Event Without Identified Device or Use Problem; Material Disintegration; Adverse Event Without Identified Device or Use Problem

  INVESTIGATION READY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20699820 ↗