N/A (REF 5921-030-135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825016142), received between Mar 7, 2018 and Feb 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 1, 2023Open, Classified

   Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.

   Z-1315-2023 · Root cause: Process control · FDA record ↗

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.

• MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WOULD NOT INFLATE ON ANY MACHINE. AS REPORTED, THE STAFF ALSO TRIED DIFFERENT INFLATION TUBES BUT IT WOULD NOT WORK. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423550 ↗
• MalfunctionOct 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TOURNIQUET WAS DEFECTIVE AS IT HAD A HOLE IN THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 25 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611159 ↗
• MalfunctionMar 7, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PRESSURE TOURNIQUET CUFF FROM THE OR DID NOT WORK. THE PRESSURE TOURNIQUET CUFF FAILED BEFORE THE SURGERY STARTED. THE TOURNIQUET WOULD NOT HOLD PRESSURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THE RISK TO THE PATIENT WAS PREDICTED AS MINIMAL BY THE SURGEON, SO THE DECISION WAS MADE TO CONTINUE WITHOUT THE USE OF A WORKING TOURNIQUET. THERE WAS AN ESTIMATED 20 CC OF BLOOD LOSS AND NO TRANSFUSION WAS REQUIRED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7322429 ↗