Tourni-Cot - Small TCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855364004030), received between Jan 2, 2026 and Jan 2, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryJan 2, 2026Improper or Incorrect Procedure or Method

  PATIENT UNDERWENT A SURGICAL PROCEDURE. THE PROCEDURE REQUIRED THE USE OF A DIGITAL TOURNIQUET, WHICH IS REMOVED AT THE END OF THE OPERATION. THE PATIENT UNDERWENT THE PROCEDURE ON THE IDENTIFIED FINGER AS PLANNED WITH THE TOURNIQUET BEING UTILISED AS PER STANDARD PRACTICE. DURING THE PROCEDURE, THE SAFETY TAG WAS REMOVED FROM THE TOURNIQUET TO AID VISIBILITY. THE PROCEDURE WAS COMPLETED AND THE PATIENT DISCHARGED HOME. UPON REVIEW IN THE OUTPATIENTS DEPARTMENT SIX DAYS LATER, THE DIGITAL TOURNIQUET WAS NOTED TO HAVE BEEN LEFT IN-SITU CAUSING THE FINGER TO BECOME SIGNIFICANTLY DAMAGED. THIS LED TO THE DIGIT BEING AMPUTATED THAT AFTERNOON.

  Patient problems: Ischemia; Necrosis; Tissue Breakdown

  MAUDE report 23952445 ↗

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