MyoSure Tissue Removal Device 50-501XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 15420045505094), received between Jun 6, 2018 and Oct 23, 2025 — classified as 1 death, 13 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A MYOSURE PROCEDURE THE PHYSICIAN WAS WORKING ON A MODERATELY CALCIFIED LARGE FIBROID. AT THE END OF THE PROCEDURE THE PHYSICIAN NOTED WHILE LOOKING THROUGH THE SCOPE THAT THERE WAS WHAT APPEARED AS "GLITTER IN THE UTERUS". PHYSICIAN REPORTED THAT THEY FLUSHED THE UTERUS WITH SALINE SOLUTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23369441 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, AT THE END OF THE MYOSURE PROCEDURE ON (B)(6) 2025, THE PATIENT HAD NO PULSE AND HAD TO BE RESUSCITATED. THE PATIENT IS NOW DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 22984827 ↗
• DeathJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT RECEIVED A MYOSURE XL PROCEDURE ON A 40 YEAR-OLD PATIENT, DURING THE PROCEDURE UP UNTIL 17 MINUTES EVERYTHING WAS DOING WELL AND TOTAL AMOUNT OF FLUID WAS 5 LITERS AND 3 LITERS SPILLED OUT OF THE PATIENT. THE HYSTEROSCOPE WAS REMOVED FROM THE PATIENT´S BODY AND THE PROCEDURE WAS ALMOST COMPLETE WHEN THE PATIENT SUDDENLY DEVELOPED ARRHYTHMIA AND AFTER 25 MINUTES OF RESUSCITATION FROM THE TEAM , THE PATIENT WAS TRANSFERRED TO THE ICU BUT DIED THE NEXT DAY. ECHOCARDIOGRAPHY WHICH DID NOT REVEAL ANYTHING. AN ABDOMINAL ULTRASOUND WAS PERFORMED AND THERE WERE NO PROBLEMS OBSERVED. PATIENT HAD A PREVIOUS HISTORY OF A MYOMECTOMY WITH RESECTOSCOPE A MONTH PRIOR TO THE PROCEDURE. THE PHYSICIAN BELIEVED THAT THE OPERATION WAS WELL PERFORMED AND THAT THE PATIENT´S DEATH HAD NOTHING TO DO WITH THE MYOSURE. THE FLUID MANAGEMENT SYSTEM WAS NOT A HOLOGIC PRODUCT. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Arrhythmia

  MAUDE report 22212851 ↗
• MalfunctionOct 11, 2024

  THERE WAS A LEAK OF SALINE AT THE JUNCTION OF TUBING NEAR THE HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425786 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), A MYOSURE PROCEDURE WAS PERFORMED, AFTER INJECTING THE PARACERVICAL ANESTHESIA AND STARTING THE MORCELLATION WITH A MYOSURE XL, THE PATIENT STARTED COUGHING AND REPORTED DIFFICULTY BREATHING. AFTER ONE MINUTE THE PATIENT INDICATES THAT SHE IS CHOKING AND ATTEMPTS TO SIT UP. THE PHYSICIANS CALLED THE ANESTHESIOLOGIST AND BEGAN TO TREAT HER. THE SITUATION BECAME COMPLICATED AND REQUIRED CPR AND TRANSFER TO THE ICU. THE DOCTOR REPORTED THAT THERE WAS NO RELATION BETWEEN WHAT HAPPENED WITH THE PATIENT AND THE HOLOGIC PRODUCTS USED. THE PATIENT IS STABLE AND HAS BEEN DEINTUBATED. SHE IS STILL IN THE HOSPITAL. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Choking; Cough; Hypoventilation

  MAUDE report 19510081 ↗
• InjuryMar 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2024, METAL FRAGMENTS WERE OBSERVED DURING THE PATIENT SURGERY, TWO DEVICES WERE USED ON THE SAME PATIENT AND BOTH EXHIBITED THE SAME ISSUES. THE PHYSICIAN STOPPED THE PROCEDURE AND ASPIRATED ALL METAL PARTS. PHYSICIAN REPORTED THAT MOST HAD BEEN REMOVED AND WILL NOT HAVE IMPACT ON THE PATIENT. PATIENT WAS A 53 YEARS OLD WOMAN , IN WHICH A MYOMA OF 2.2 WAS REMOVED. NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18970136 ↗
• InjuryMar 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2024, METAL FRAGMENTS WERE OBSERVED DURING THE PATIENT SURGERY, TWO DEVICES WERE USED ON THE SAME PATIENT AND BOTH EXHIBITED THE SAME ISSUES. THE PHYSICIAN STOPPED THE PROCEDURE AND ASPIRATED ALL METAL PARTS. PHYSICIAN REPORTED THAT MOST HAD BEEN REMOVED AND WILL NOT HAVE IMPACT ON THE PATIENT. PATIENT WAS A 53 YEARS OLD WOMAN , IN WHICH A MYOMA OF 2.2 WAS REMOVED. NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18970060 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) A MYOSURE PROCEDURE WAS PERFORMED AND DURING THE PROCEDURE, THE DOCTOR WAS RESECTING A CALCIFIED FIBROID AND HAD USED 2 XL DEVICES THAT HAD BOTH BECOME DULL FROM CUTTING AND WAS OPENING A 3RD DEVICE TO CONTINUE REMOVAL. THE DOCTOR PLUGGED IN THE 3RD DEVICE AND BEGAN TO CONTINUE THE RESECTION. THE DOCTOR WAS APPLYING SOME PRESSURE/TORQUE TO THE DEVICE TO KEEP CUTTING THE FIBROID. THERE WAS AN AUDIBLE CHANGE IN SOUND, THEN THE VIBRATION STOPPED, THEN THE MACHINE STOPPED. DURING RESECTION WITH THE 3RD DEVICE, THE SCREEN ON THE MYOSURE CONTROL UNIT WENT BLACK AND THE DEVICE STOPPED. THE DOCTOR REMOVED THE DEVICE AND STAFF POWER CYCLED THE CONTROL UNIT TO CONTINUE THE PROCEDURE. THE DOCTOR REINTRODUCED THE SCOPE AFTER THE POWER CYCLE AND VISUALIZED METAL SHAVINGS IN THE CAVITY. THE DOCTOR THEN OPENED A MYOSURE REACH TO TRY AND REMOVE THE METAL SHAVINGS FROM THE CAVITY. IT WAS REMOVED AS MANY SHAVINGS AS POSSIBLE AND THE DOCTOR CHOSE TO ABORT THE PROCEDURE AS THEY WERE APPROACHING THE DEFICIT LIMIT. AT THIS TIME, THE PATIENT IS NOT BEING KEPT FOR FURTHER OBSERVATION AND WAS NOT PROVIDED WITH ANY ADDITIONAL MEDICATION OR TREATMENT. NO ADDITIONAL INFORMATION

  Patient problems: Foreign Body In Patient

  MAUDE report 18857070 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 12TH A MYOSURE PROCEDURE WAS PERFORMED AND DURING THE PROCEDURE, THE DOCTOR PAUSED THE USE OF MYOSURE AS SHE STATED THAT SHE FELT LIKE SHE WAS NOT MAKING MUCH PROGRESS ON REMOVING THE FIBROID. THE DOCTOR THEN ATTEMPTED TO USE POLYP FORCEPS TO REMOVE THE REMAINDER OF THE FIBROID. WHEN THE DOCTOR RE-ENTERED THE CAVITY WITH THE SCOPE, IT WAS OBSERVED WHAT SEEMED TO BE A FALSE PASSAGE FURTHER PAST THE NATURAL CAVITY. THE PROCEDURE WAS ENDED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 17900988 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) A MYOSURE PROCEDURE WAS PERFORMED AND DURING THE PROCEDURE, THE DOCTOR PAUSED THE USE OF MYOSURE AS SHE STATED THAT SHE FELT LIKE SHE WAS NOT MAKING MUCH PROGRESS ON REMOVING THE FIBROID. THE DOCTOR THEN ATTEMPTED TO USE POLYP FORCEPS TO REMOVE THE REMAINDER OF THE FIBROID. WHEN THE DOCTOR RE-ENTERED THE CAVITY WITH THE SCOPE, IT WAS OBSERVED WHAT SEEMED TO BE A FALSE PASSAGE FURTHER PAST THE NATURAL CAVITY. THE PROCEDURE WAS ENDED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 17900982 ↗
• InjuryMar 2, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A 44 YEARS OLD PATIENT UNDERWENT A MYOSURE ABLATION PROCEDURE IN (B)(6) 2023 / (B)(6) 2023. THE DEVICE WAS SUCCESSFULLY TESTED TESTING PRIOR TO USE AND IT WAS USED IN THE PROCEDURE WITHOUT ANY MALFUNCTIONS. HOWEVER, AT THE END OF THE PROCEDURE, THE DISPOSABLE DEVICE WAS NOT REMOVED PRIOR TO THE HYSTEROSCOPE REMOVAL AS EXPECTED: WHEN REMOVING THE HYSTEROSCOPE, THE DEVICE WAS STILL WITHIN THE HYSTEROSCOPE AND WAS PROTRUDING THROUGH THE DISTAL END OF THE HYSTEROSCOPE. THE SURGEON¿S FOOT WAS EITHER STILL ON THE FOOT PEDAL AND/OR SHE PRESSED THE FOOT PEDAL ON REMOVING THE INSTRUMENTATION. AS A RESULT ON REMOVAL, THE MYOSURE DEVICE RESECTED VAGINAL TISSUE WHICH LEAD TO ANTERIOR VAGINAL WALL AND URETHRAL DAMAGE. A SURGICAL REPAIR WAS IMMEDIATELY REQUIRED AND THE PATIENT HAS BEEN CATHETERIZED WHICH IS TO REMAIN IN-SITU FOR 3-MONTHS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vaginal Mucosa Damage

  MAUDE report 16473276 ↗
• MalfunctionAug 22, 2022Disconnection

  WHITE CORD PULLED AWAY FROM DEVICE DURING CASE.

  Patient problems: Insufficient Information

  MAUDE report 15264715 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A MS PROCEDURE ON (B)(6) 2022 TO REMOVE RETAINED PRODUCTS OF CONCEPTION UPPER LEFT UTERINE CAVITY AND LEFT UTERINE SIDE WALL. DURING THE SURGERY, THE MS BLADE CONTINUED TO RUN, EVEN THOUGH THE DOCTOR HAS STOPPED THE FOOT PEDAL. THE NURSE STATED THERE WAS GOOD VISION THROUGH OUT THE MS PROCEDURE, AND THAT THE DOCTOR HAD THEN ADVISED TO STOP USING THE MYOSURE, AND TO USE THE RESECTOSCOPE. THE NURSE NOTICED WHEN USING RESECTOSCOPE, IN CONJUNCTION WITH AQUILEX, THAT THE FLUID DEFICIT WAS GOING UP FAST- AND THEN HAD ALERTED DOCTOR. THE DOCTOR WENT BACK AND HAD NOTICED THERE WAS A PERFORATION, IMMEDIATELY COMMENCED LAPAROSCOPIC PROCEDURE. THEY THINK THE PERFORATION IS DUE TO THE MS MALFUNCTION. ¨PHYSICIAN REPORTED THE FOLLOWING: RETROSPECTIVE DOCUMENTATION OF DISCUSSION TAKEN BETWEEN THE PATIENT AND THE PHYSICIAN: THE HOLOGIC MYOSURE HAD AN INTERMITTENT FAULT WHICH RESULTED IN PULSATILE ACTIVITY OF THE DEVICE´S PISTON FOR ABOUT 3 SECONDS. THE DEVICE THEREFORE WORKED INTERMITTENTLY AND IT WAS DIFFICULT TO ACHIEVE A CONSTANT FLOW THROUGH OF SALINE OPTIMIZING VISIBILITY. THE PRODUCTS OF CONCEPTION WERE READILY IDENTIFIED IN THE LOWER LEFT UTERINE CAVITY AND THESE WERE IN

  Patient problems: Uterine Perforation

  MAUDE report 15126564 ↗
• MalfunctionNov 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON AN UNKNOWN DATE , METAL SHAVINGS WERE FOUND INSIDE THE UTERINE CAVITY , NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12739505 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MAY 6TH A PATIENT RECEIVED A MYOSURE PROCEDURE AND HAD TO BE ADMITTED TO THE POST ANESTHESIA CARE UNIT DUE TO A PERSISTENT BLEEDING CAUSE BY A FIBROID THAT COULD NOT BE COMPLETELY RESECTED. THE PATIENT RECEIVED A UTERINE ARTERY EMBOLIZATION AND WAS DISCHARGED WITHOUT ISSUES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11939930 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT ON (B)(6) 2020 A PHYSICIAN PERFORMED A MYOSURE PROCEDURE ON A PATIENT , WITH THE AQUILEX FLUID PUMP, DURING THE PROCEDURE THE FLUID DEFICIT WENT UP TO 2135 SO THE SURGEON WANTED TO CHECK FOR PERFORATION IN UTERUS. HYSTEROSCOPY WAS DONE AND UNABLE TO DETECT IF A PERFORATION HAD OCCURRED SO IT WAS DECIDED TO PERFORM A DIAGNOSTIC LAPAROSCOPY. THE LAPAROSCOPY REVEALED NO PERFORATION IN UTERUS NOR BLOOD IN ABDOMEN. NO OTHER FINDINGS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10829629 ↗
• MalfunctionOct 22, 2019Leak/Splash

  MYOSURE XL HAND PIECE LEAKING AT BASE OF HAND PIECE AND TUBING CONNECTION. REPLACED W/ ANOTHER MYOSURE XL WHICH WORKED WELL AS DESCRIBED IN THE PROCEDURAL NOTES...."THE MYOSURE REACH WAS INSERTED THROUGH THE OPERATIVE HYSTEROSCOPE INTO THE ENDOMETRIAL CAVITY AND THE TWO VISUALIZED POLYPS WERE RESECTED. AFTER THE POSTERIOR FUNDAL POLYP WAS REMOVED, THE BILATERAL TUBAL OSTIA WERE VISUALIZED AND NO ABNORMALITIES WERE NOTED. THE MYOSURE REACH WAS THEN REMOVED AND REPLACED WITH THE MYOSURE XL WHICH WAS USED TO REMOVE THAT PORTION OF THE SUBMUCOSAL FIBROID THAT WAS PROTRUDING INTO THE ENDOMETRIAL CAVITY." NO ADVERSE PATIENT OUTCOMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9218176 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, A SCOPE WAS USED TO VISUALIZE THE CAVITY. IT APPEARED THERE WERE TWO HOLES AT THE FUNDUS OF THE UTERUS BUT THEY WERE BELIEVED TO BE SCAR TISSUE. THE DEFICIT WAS MAINTAINING AND NOT RISING. THE TISSUE REMOVAL DEVICE WAS INSERTED INTO THE CAVITY, VISUALIZATION WAS LOST AND THE FLUID DEFICIT SPIKED. THE DEVICE WAS REMOVED. ABDOMINAL AND VAGINAL ULTRASOUNDS WERE PERFORMED AND THERE WAS NO FLUID FOUND IN PATIENT ABDOMEN. THE DEVICE WAS DISCARDED AND THE PROCEDURE WAS ABORTED. PATIENT WAS BEING WATCHED IN OBSERVATION ROOM. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 8899477 ↗
• MalfunctionApr 9, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE TISSUE REMOVAL THE PHYSICIAN NOTED A METALLIC FRAGMENT IN THE PATIENT'S UTERUS. "IT CAME OUT AND WAS COLLECTED IN THE TISSUE TRAP WHERE IT WAS SENT TO PATHOLOGY TO BE EXAMINED." THE PROCEDURE WAS COMPLETED. NO INJURY REPORTED. ADDITIONAL INFORMATION NOTED THAT PATHOLOGY DID IDENTIFY A METALLIC FRAGMENT IN THE SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496002 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN PERFORMED A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL ON (B)(6) 2018, AND THE PATIENT WAS "ACTIVELY BLEEDING" AT THE FIBROID REMOVAL SITE. THE PATIENT HAD LOW HEMOGLOBIN (HB) AND THE PHYSICIAN ABORTED THE PROCEDURE. THE PHYSICIAN INSERTED A CATHETER TO TRY AND TAMPONADE THE BLEEDING. THE PATIENT CONTINUED TO BLEED AND THE PHYSICIAN DECIDED TO PROCEED WITH A LAPAROSCOPIC HYSTERECTOMY. THE PATIENT RECEIVED A BLOOD TRANSFUSION INTRAOPERATIVELY. THE FINDINGS WERE THE PATIENT HAD A BULKY UTERUS WHICH WAS THOUGHT TO HAVE UNDERLYING PATHOLOGY CAUSING THE INTERMITTENT CYCLIC BLEEDING. THE PATIENT RECOVERED WELL AND WAS DISCHARGED THE NEXT MORNING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7575124 ↗