Color Cuff 5921212235Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154599714), received between Apr 12, 2019 and Apr 24, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2019Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 2 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 8545835 ↗
• MalfunctionApr 12, 2019Decrease in Pressure; Decrease in Pressure

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE CUSTOMER ATTEMPTED TO INFLATE THE CUFF, THE CUFF DID FILL UP, BUT DID NOT STAY FULL. THE POSSIBLE HARM ASSOCIATED WITH THIS EVENT IS BLOOD LOSS AND IF THIS TYPE OF MALFUNCTION WERE TO REOCCUR DURING A BIER BLOCK PROCEDURE, IT COULD POSE THE RISK OF SYSTEMIC EXPOSURE TO LOCAL ANESTHETIC. THERE WERE NO REPORTED 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 8508810 ↗