Color Cuff 5921030135Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613154599417), received between Apr 24, 2019 and Sep 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (8 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Decrease in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946351 ↗
• MalfunctionMay 29, 2026Decrease in Pressure

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TOURNIQUET EXPERIENCED A LEAK. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330685 ↗
• MalfunctionMar 25, 2026Decrease in Pressure

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY TWO TOURNIQUETS TEARING AT THE SEAMS AND NOT HOLDING PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690846 ↗
• MalfunctionJul 10, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE LEAKING AIR DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467460 ↗
• MalfunctionOct 22, 2021Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680371 ↗
• MalfunctionJul 21, 2021Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 13 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 12 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204177 ↗
• MalfunctionJun 4, 2020Device Alarm System; Decrease in Pressure; Device Alarm System; Decrease in Pressure

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE TOURNIQUET CUFF KEPT ALARMING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10121043 ↗
• MalfunctionApr 24, 2019Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE DECREASED IN PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545859 ↗