DEFENDO Defendo Fujifilm 700 Series (REF 100333)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995228941), received between May 1, 2024 and Jan 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Leak/Splash

  THE DISTRIBUTOR REPORTED THAT THE BUTTON ON THE DEFENDO SINGLE USE VALVE KIT IS LEAKING DURING PATIENT PROCEDURES. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007450 ↗
• MalfunctionMay 1, 2024Suction Problem; Suction Problem

  THE USER FACILITY REPORTED THAT DURING THREE PATIENT PROCEDURES INCLUDING USE OF A DEFENDO SINGLE USE SUCTION VALVE, THERE WAS LACK OF SUCTION RESULTING IN PROCEDURE DELAYS. IN ADDITION, THE SUCTION WAS LEAKING WHEN SEATED AND WAS REPORTED AS NOT BEING AS POWERFUL AS PREVIOUS VALVES. IT WAS REPORTED THAT DURING ONE OF THE THREE PROCEDURES, THE USER WAS SPRAYED IN THE FACE ONCE WITH STERILE WATER. ALL PROCEDURES WERE COMPLETED SUCCESSFULLY WITH REPLACEMENT VALVES. NO REPORT OF INJURY. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226075 ↗