Halyard LLOF1500-15_0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160339633), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Break; Break

  AVID MEDICAL RECEIVED A COMPLAINT ON 03/10/23 ORIGINATED BY 1047429-2023-00002 STATING THAT SCALPELS IN OUR PROCUREMENT PACKS ARE BREAKING IN THE MIDDLE OF THE SCALPEL DUE TO BRITTLE HANDLES. NO INJURY WAS REPORTED TO EITHER PATIENT OR HEALTH CARE PERSONNEL. THIS KIT IS USED FOR TISSUE PROCUREMENT FROM A DECEASED DONOR. AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY - REF LLOF1500-15 CLEANING & CUTTING TRAY THAT INCLUDES THE FOLLOWING COMPONENT: SCALPEL #21 DISPOSABLE, VENDOR REF 6000CST-21 SUPPLIED BY MYCO MEDICAL SUPPLIES INC.

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

  MAUDE report 16701832 ↗