Tourni-Cot - Universal TCURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855364004085), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K853472); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• InjuryNov 5, 2020Detachment of Device or Device Component; Device Handling Problem; Unclear Information; Detachment of Device or Device Component; Device Handling Problem; Unclear Information

  FINGER TOURNIQUET WAS LEFT INSITU FOLLOWING LOCAL ANAESTHETIC PROCEDURE. IT IS UNKNOWN WHETHER IT WAS PART OR THE WHOLE DEVICE. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): THE (B)(6) YEAR OLD PATIENT'S FINGER HAD DRY GANGRENE WHICH HAD TO BE AMPUTATED. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER) DEVICE REMOVED FROM USE.

  Patient problems: Tissue Breakdown

  MAUDE report 10795761 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K853472. One submission often covers many models, so check the product and lot details in each record.

• Z-0945-2021 · Dec 28, 2020 · Terminated
  Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide