DeRoyal 35-401106Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756371803), received between Apr 5, 2023 and Jul 28, 2025 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  A USER FACILITY REPORTED, "CUSTOMER NOTES THEY WERE INJECTING USING HIGH PRESSURE AND IT LEAKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639306 ↗
• MalfunctionSep 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  MEDICAL PROFESSIONAL WAS UNABLE TO BALANCE TRANSDUCER DURING PROCEDURE. CUSTOMER DID TROUBLE SHOOTING DIFFERENT CABLES BUT DETERMINED ISSUE WAS WITH TRANSDUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842539 ↗
• MalfunctionApr 5, 2023No Apparent Adverse Event; No Apparent Adverse Event

  MEDICAL PROFESSIONAL WAS UNABLE TO BALANCE TRANSDUCER DURING PROCEDURE. CUSTOMER DID TROUBLE SHOOTING DIFFERENT CABLES BUT DETERMINED ISSUE WAS WITH TRANSDUCER. LENGTH OF DELAY WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682692 ↗