Color Cuff 5922030135Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613154600052), received between Jan 22, 2021 and Apr 22, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CUFF WAS LEAKING DURING SETUP 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 19153808 ↗
• MalfunctionApr 22, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CUFF WAS LEAKING DURING SETUP 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 19153806 ↗
• MalfunctionFeb 22, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CUFF WAS LEAKING DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

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

  MAUDE report 18756693 ↗
• MalfunctionJun 15, 2023Decrease in Pressure; Decrease in Pressure

  THE DEVICE HAD LEAKAGE AND FAILED TO INFLATE DURING A SERVICE EVALUATION AT THE OUS SERVICE 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 17133698 ↗
• MalfunctionJan 10, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING USE IN A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS LEAKING WHILE INFLATING, A CONDITION IN WHICH THE DEVICE MAY NOT HOLD THE CORRECT PRESSURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134075 ↗
• MalfunctionJan 6, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING USE IN A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WOULD NOT INFLATE PROPERLY AND WAS LEAKING AIR, A CONDITION IN WHICH THE DEVICE MAY NOT HOLD THE CORRECT PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111052 ↗
• MalfunctionDec 29, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING USE IN A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WOULD NOT INFLATE PROPERLY AND WAS LEAKING AIR, A CONDITION IN WHICH THE DEVICE MAY NOT HOLD THE CORRECT PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070981 ↗
• MalfunctionDec 29, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING USE IN A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WOULD NOT INFLATE PROPERLY AND WAS LEAKING AIR, A CONDITION IN WHICH THE DEVICE MAY NOT HOLD THE CORRECT PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070978 ↗
• MalfunctionJan 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 NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11218232 ↗