AVID TruCustom WHEE005-14_0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160279441), received between May 21, 2021 and May 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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.

• MalfunctionMay 21, 2021Component Misassembled; Component Misassembled

  COMPLAINT #: (B)(4) RINGS FROM LAP SPONGES BROKE INTO PIECES AND FELL INTO THE PATIENT ABDOMINAL CAVITY. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 21 STATING THAT RINGS FROM LAP SPONGES BROKE INTO PIECES AND FELL INTO THE PATIENTS ABDOMINAL CAVITY AND HAD TO BE RETRIEVED. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER ALLCARE INC CONCERNING THE ISSUE OF THE RINGS BREAKING APART FOR ITEM NO. AL1818R-800, MANUFACTURER LOT# 21SK02. NO PATIENT INJURY WAS REPORTED. THE BROKEN RING PIECES WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT¿¿S ABDOMINAL CAVITY FOLLOWING THE INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11863029 ↗