N/A (REF 5921-218-135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885825016500), received between Mar 27, 2023 and Mar 30, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS NOT HOLDING PRESSURE. 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 16651445 ↗
• MalfunctionMar 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE TOURNIQUET CUFF DID NOT HOOK UP PROPERLY AND LEAKED AIR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS NO MORE THAN 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632587 ↗
• MalfunctionMar 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TOURNIQUET CUFFS LEAKED PUMP ERRORS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632166 ↗
• MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TOURNIQUET CUFF, THE DESIRED PRESSURE WASN'T BEING REACHED AND COULDN'T HOLD AIR. THE PUMP KEPT TRYING TO INFLATE THROUGHOUT THE CASE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624774 ↗
• MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TOURNIQUET CUFF MALFUNCTIONED. THE PUMP KEPT TRYING TO INFLATE THROUGHOUT THE CASE BECAUSE THE DESIRED PRESSURE WASN'T BEING REACHED AND COULDN'T HOLD AIR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624771 ↗