Color Cuff 5921-034-135NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327606171), received between Jan 29, 2023 and Jun 12, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (20 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Mar 1, 2023Class IIOpen, Classified

   Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

   Z-1341-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17113966 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17113793 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17113678 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED, THAT THE DEVICE WAS FAILING TO INFLATE. DURING INITIAL TESTING 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 17113464 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17113412 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17113375 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED, THAT THE DEVICE WAS FAILING TO INFLATE. DURING INITIAL TESTING 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 17112987 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED, THAT THE DEVICE WAS FAILING TO INFLATE. DURING INITIAL TESTING 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 17112986 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17112984 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17112975 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED, THAT THE DEVICE WAS FAILING TO INFLATE. DURING INITIAL TESTING 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 17112970 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED, THAT THE DEVICE WAS FAILING TO INFLATE. DURING INITIAL TESTING 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 17112967 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17112935 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17112929 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17112686 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17112676 ↗
• MalfunctionJun 12, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS FAILING TO INFLATE DURING INITIAL TESTING 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 17112652 ↗
• MalfunctionApr 19, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WOULD NOT HOLD PRESSURE DURING A CASE 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 16773840 ↗
• MalfunctionMar 7, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 68 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 65 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500404 ↗
• MalfunctionJan 29, 2023Decrease in Pressure; Decrease in Pressure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261812 ↗