HYSAFE 86426508Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207027790), received between Nov 4, 2025 and Nov 4, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY BIOPSY, THE HEALTHCARE PHYSICIAN WAS UNABLE TO TAKE A SAMPLE OF TISSUE OR POLYPS USING THE INSTRUMENT. THERE IS NO REPORT OF INJURY OR UNACCEPTABLE RISKS, HOWEVER THE PLANNED PROCEDURE COULD NOT BE COMPLETED SINCE THERE WAS NO BACK-UP DEVICE. LATER, THE PATIENT WAS REFERRED TO ANOTHER HEALTHCARE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468874 ↗
• InjuryNov 4, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY BIOPSY, THE HEALTHCARE PHYSICIAN WAS UNABLE TO TAKE A SAMPLE OF TISSUE OR POLYPS USING THE INSTRUMENT. THERE IS NO REPORT OF INJURY OR UNACCEPTABLE RISKS, HOWEVER THE PLANNED PROCEDURE COULD NOT BE COMPLETED SINCE THERE WAS NO BACK-UP DEVICE. LATER, THE PATIENT WAS REFERRED TO ANOTHER HEALTHCARE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468859 ↗