Color Cuff 5921-034-235NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327606188), received between Jan 29, 2023 and May 11, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (3 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-1342-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS SET AT 250 BUT WOULD NOT REACH THAT NUMBER DURING USE IN A PROCEDURE AT THE USER FACILITY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912299 ↗
• MalfunctionMar 7, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 44 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 42 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

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

  MAUDE report 16500405 ↗
• 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 NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261808 ↗