DeRoyal 89-10540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756364454), received between May 20, 2022 and Nov 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. 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.

• MalfunctionNov 5, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND INSIDE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608667 ↗
• MalfunctionJun 29, 2022Material Puncture/Hole; Material Puncture/Hole

  OUTER DRAPE FROM DEROYAL CMC CAROTID PACK ARRIVED WITH HOLE IN DRAPE. OUTER PLASTIC PACKAGING NOT AFFECTED THEREFORE HOLE OCCURRED DURING MANUFACTURING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14850310 ↗
• MalfunctionMay 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  RED CRUSTY SUBSTANCE ON SUCTION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461585 ↗