Color Cuff 5921034135Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613154599455), received between Sep 28, 2018 and Jul 8, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE NOT HOLDING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691164 ↗
• MalfunctionJan 29, 2023Decrease 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261798 ↗
• 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 13289679 ↗
• MalfunctionOct 28, 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 PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715265 ↗
• MalfunctionJul 21, 2021Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 28 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 13 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 15 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204166 ↗
• MalfunctionApr 26, 2021Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729191 ↗
• MalfunctionJan 22, 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 PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11218291 ↗
• MalfunctionOct 28, 2020Decrease 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 10748296 ↗
• MalfunctionJul 1, 2020Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE TOURNIQUET HAD A HOLE IN IT AND WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10221145 ↗
• MalfunctionOct 28, 2019Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> 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; No Known Impact Or Consequence To Patient

  MAUDE report 9245221 ↗
• MalfunctionApr 24, 2019Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE DECREASED IN PRESSURE. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545837 ↗
• MalfunctionNov 29, 2018Decrease in Pressure; Decrease in Pressure

  THE SALES REPRESENTATIVE REPORTED THAT THE CUFF DID NOT HOLD PRESSURE DURING A PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8115402 ↗
• MalfunctionSep 28, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  THE USER FACILITY REPORTED THAT WHEN THE TOURNIQUET CUFF WAS PLACED ON THE PATIENT DURING A PROCEDURE, THE SEAM SPLIT OPEN AND WOULD NOT INFLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919282 ↗