N/A (REF 60-7070-005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825015411), received between Feb 2, 2017 and Dec 5, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. May 31, 2024Open, Classified

   Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.

   Z-2405-2024 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PRESSURE TOURNIQUET CUFF LEAKED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. EXTENDED PROCEDURE TIME REPORTED WAS UNDER 5 MINUTES TO GRAB NEW PRODUCT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BREAKTHROUGH OR EXCESSIVE BLEEDING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085079 ↗
• MalfunctionFeb 2, 2017Leak/Splash

  IT WAS REPORTED THE 30" TOURNIQUET CUFF LEAKED PRIOR TO PLACEMENT. THE CUFF WAS TESTED PRIOR TO PUTTING ON THE PATIENT, BUT WAS AUDIBLY LEAKING. THE CUFF WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6297338 ↗