Myosure Manual Tissue Removal Device 20-401MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045507937), received between Dec 16, 2022 and Dec 5, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THAT THERE WAS A MISSING BLADE. IT WAS NOTICED AS THE PHYSICIAN WAS TRYING TO REMOVE THE POLYP FROM THE PATIENT. THERE WERE NO UNUSUAL SOUNDS OR PIECES OBSERVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727962 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A MYOSURE MANUAL PROCEDURE, THE CUSTOMER REPORTED THAT THE BLADE WAS NOT OPENING AND CLOSING FULLY. ONCE THE PROCEDURE WAS OVER WHEN REMOVING THE SPECIMEN CAPTURE CONTAINER, IT SPILLED AND SOME OF THE TISSUE WAS POSSIBLE LOST. ONCE THE CONTAINER WAS OFF FROM THE DEVICE IT APPEARED TO OPEN AND CLOSE PROPERLY. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21885822 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 26, A MYOSURE PROCEDURE WAS PERFORMED TO REMOVE A UTERINE POLYP AND DURING THE PROCEDURE A GREEN PLASTIC WAS COMING OUT OF THE DEVICE, AT THE END OF THE PROCEDURE THE GREEN PLASTIC FELL INSIDE THE PATIENT'S CAVITY AND THE DCOTOR HAD TO REMOVED THE MATERIAL. THE PATIENT WAS DISCHARGED HOME. ALL VISUALIZED PLASTIC PIECES WERE COLLECTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20364147 ↗
• MalfunctionAug 22, 2024Material Disintegration; Material Disintegration

  IT WAS REPORTED 5 A MYOSURE PROCEDURE WAS PERFORMED AND IT WAS FOUND THAT THE TISSUE COLLECTION TRAP CONTAINED GREEN DEBRIS NOT NORMALLY SEEN. IT WAS CONFIRMED THAT THIS MATERIAL WAS NOT SEEN INSIDE THE PATIENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044674 ↗
• InjuryDec 16, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6)2022 , A MYOSURE PROCEDURE WAS PERFORMED AND DURING THE PROCEDURE, THE BLADE DIDN'T CUT A SMALL POLYP TISSUE THAT WAS INTENDED TO BE REMOVED BY THE PHYSICIAN. THE PROCEDURE WAS ABORTED SINCE THEY DID NOT HAVE ANOTHER BLADE AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999907 ↗