Color Cuff 5921-218-135NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327606133), received between Mar 7, 2023 and Dec 22, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (5 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-1343-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE INFLATED AND THEN DEFLATED DURING 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 18380911 ↗
• MalfunctionDec 21, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE INFLATED AND THEN DEFLATED DURING 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 18371747 ↗
• MalfunctionDec 21, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE INFLATED AND THEN DEFLATED DURING 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 18371745 ↗
• MalfunctionApr 4, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT CUFF LEAKED AIR DURING USE IN 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 16676286 ↗
• MalfunctionMar 7, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 50 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 34 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 15 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED.

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

  MAUDE report 16500408 ↗