MyoSure Tissue Removal DeviceRecalls & reported problems across all models

We found 4 models of MyoSure Tissue Removal Device by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2018 and Sep 24, 2026 — classified as 2 deaths, 41 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (15 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 MyoSure Tissue Removal Device problems

MyoSure Tissue Removal Device models

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

• MyoSure Tissue Removal Device 30-401LITE

  HYSTEROSCOPE (AND ACCESSORIES)
  1 death60 reports
• MyoSure Tissue Removal Device 50-501XL

  HYSTEROSCOPE (AND ACCESSORIES)
  1 death20 reports
• MyoSure Tissue Removal Device 10-401

  HYSTEROSCOPE (AND ACCESSORIES)
  1 report
• MyoSure Tissue Removal Device 40-902

  HYSTEROSCOPE (AND ACCESSORIES)
  1 report

Recent MyoSure Tissue Removal Device adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 3, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING A MYOSURE/OMNI PROCEDURE ON (B)(6) 2026, THE PHYSICIAN WAS USING AN OMNI SCOPE FOR HYSTEROSCOPY AND BEGAN A MYOSURE PROCEDURE USING A REACH DEVICE. AFTER INSERTING THE MYOSURE REACH THROUGH THE SCOPE THE PHYSICIAN VISUALIZED WHAT WAS BELIEVE TO BE A PIECE OF PLASTIC ON THE DISTAL END OF THE MYOSURE DEVICE. THE DEVICE HAD NOT BEEN ACTIVATED AFTER BEING INSERTED INTO THE SCOPE AND THE MATERIAL WAS SEEN BEFORE ANY USE OF THE DEVICE IN THE PATIENT. THE PHYSICIAN REMOVED THE SCOPE FROM THE PATIENT AND THE TECH REMOVED THE PIECE FROM THE END OF THE DEVICE. THE PIECE WAS REPORTED AS APPEARED A PIECE OF THE SCOPE SEAL FROM THE END OF THE SCOPE. STAFF REPORTED THAT THERE WAS NO MATERIAL OBSERVED ON THE END OF THE DEVICE PRIOR TO INSERTION INTO THE PATIENT. THE MATERIAL WAS DISCARDED AND THE PHYSICIAN CONTINUED THE PROCEDURE WITHOUT OBSERVING ANY ADDITIONAL MATERIAL IN THE UTERUS. THE PHYSICIAN REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED AND NO MEDICAL INTERVENTION REQUIRED. STAFF EXAMINED THE SCOPE SEAL AT THE END OF THE PROCEDURE AND DETERMINED THAT IT DID APPEAR AS A PIECE OF THE SEAL HAD BEEN BROKEN OFF. CUSTOMER WAS UNAB

  Patient problems: Foreign Body In Patient

  MAUDE report 24501158 ↗
• 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 ↗

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