Color Cuff 5921034235Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613154599479), received between Jun 25, 2018 and Mar 26, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Decrease in Pressure

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TOURNIQUET WOULD NOT STAY INFLATED. 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 24697252 ↗
• MalfunctionJan 16, 2026Decrease in Pressure

  IT WAS REPORTED THAT THE CUFF DEVICE WAS UP FOR 10 MINUTES THEN DEFLATED. THEY CHECKED CONNECTIONS AND REINFECTED THE CUFF BUT THEN THE ALARM WENT OFF. THEY HEARD A LEAK ALONG THE SEAM OF THE CUFF. 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 24099197 ↗
• MalfunctionNov 13, 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 23543180 ↗
• MalfunctionAug 4, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING TAKING BLOOD PRESSURE THE DEVICE WOULD NOT INFLATE AT THE USER FACILITY. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 22707247 ↗
• MalfunctionMar 24, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS DEFLATING WHILE IN USE. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16613312 ↗
• MalfunctionMar 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TOURNIQUET CUFF WAS NOT HOLDING PRESSURE DURING CASE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16604389 ↗
• MalfunctionMar 21, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING BEFORE A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584329 ↗
• MalfunctionMar 21, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING BEFORE A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584323 ↗
• MalfunctionMar 21, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING BEFORE A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584320 ↗
• MalfunctionMar 21, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING BEFORE A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584293 ↗
• MalfunctionMar 20, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING BEFORE A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577377 ↗
• MalfunctionMar 20, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING BEFORE A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577339 ↗
• MalfunctionMar 7, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500411 ↗
• MalfunctionJan 29, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261802 ↗
• MalfunctionOct 25, 2022Decrease in Pressure; Decrease in Pressure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666675 ↗
• MalfunctionJan 19, 2022Decrease in Pressure; Decrease in Pressure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289814 ↗
• MalfunctionOct 22, 2021Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. - 5 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 2 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680369 ↗
• MalfunctionApr 26, 2021Decrease in Pressure; Decrease in Pressure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729114 ↗
• MalfunctionJul 23, 2019Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE WOULD NOT HOLD PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816433 ↗
• MalfunctionAug 7, 2018Decrease in Pressure; Pressure Problem; Decrease in Pressure; Pressure Problem

  THE TOURNIQUET CUFF LOST INFLATION DURING A PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7757012 ↗
• MalfunctionJun 25, 2018Decrease in Pressure; Pressure Problem; Decrease in Pressure; Pressure Problem

  THE SALES REPRESENTATIVE REPORTED THAT THE USER FACILITY USED A TOURNIQUET WHERE ONE OF THE PORTS OF THE TOURNIQUET WAS NOT SECURELY ATTACHED, RESULTING IN A LOSS OF PRESSURE. THERE WERE NO ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7633660 ↗