NIBP Cuffs EASY CARE CUFF, 1 HOSE, ADULT (1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838003095), received between Apr 4, 2025 and May 7, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE BLOOD PRESSURE CUFF DID NOT DEFLATE, CAUSING HARM TO THE PATIENT'S ARM. AFTER THE PATIENT WAS AWAKENED AND EXTUBATED FOLLOWING SURGERY, IT WAS DISCOVERED THE PATIENT'S ARM WAS SWOLLEN FROM THE ELBOW DOWN WITH RED AND BLACK AND BLUE AREAS. NO IV LINES WERE PRESENT IN THE ARM AT THE TIME. AT THIS TIME, THE CUFF WAS LOOSE ENOUGH FOR STAFF TO PUT A FINGER IN BETWEEN THE ARM AND THE CUFF; HOWEVER, MARKS WERE VISIBLE ON THE ARM INDICATING THE CUFF WAS AT SOME POINT VERY TIGHT. THE ON CALL NEUROSURGICAL, ORTHOPEDIC, AND VASCULAR SURGERY PHYSICIANS WERE CONSULTED IN THE OPERATING ROOM TO CONSULT. IT REMAINS UNKNOWN WHETHER THERE WAS ANY INTERVENTION REQUIRED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977613 ↗
• MalfunctionApr 4, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE BLOOD PRESSURE CUFF DID NOT DEFLATE, CAUSING HARM TO THE PATIENT'S ARM. AFTER THE PATIENT WAS AWAKENED AND EXTUBATED FOLLOWING SURGERY, IT WAS DISCOVERED THE PATIENT'S ARM WAS SWOLLEN FROM THE ELBOW DOWN WITH RED AND BLACK AND BLUE AREAS. NO IV LINES WERE PRESENT IN THE ARM AT THE TIME. AT THIS TIME, THE CUFF WAS LOOSE ENOUGH FOR STAFF TO PUT A FINGER IN BETWEEN THE ARM AND THE CUFF; HOWEVER, MARKS WERE VISIBLE ON THE ARM INDICATING THE CUFF WAS AT SOME POINT VERY TIGHT. THE ON CALL NEUROSURGICAL, ORTHOPEDIC, AND VASCULAR SURGERY PHYSICIANS WERE CONSULTED IN THE OPERATING ROOM TO CONSULT. IT REMAINS UNKNOWN WHETHER THERE WAS ANY INTERVENTION REQUIRED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Bruise/Contusion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777669 ↗
• MalfunctionApr 4, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE NON-INVASIVE BLOOD PRESSURE (NIBP) CUFF DID NOT DEFLATE, CAUSING HARM TO THE PATIENT'S ARM. IT WAS INDICATED THE ARM TURNED BLUE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21776547 ↗
• InjuryApr 4, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE BLOOD PRESSURE CUFF DID NOT DEFLATE, CAUSING HARM TO THE PATIENT'S ARM. AFTER A LONG OPERATION WITH THE PATIENT IN THE SUPINE POSITION, IT WAS OBSERVED THE PATIENT'S RIGHT ARM WAS DARK RED WITH BLACK AND BLUE AREAS AND THEIR FINGERS WERE SWOLLEN. THE PATIENT COMPLAINED OF PAIN IN THEIR ARM UPON WAKING. AFTER REMOVING THE DRAPING, THE BLOOD PRESSURE CUFF WAS LOOSE BUT MARKS ON THE ARM INDICATED THE CUFF MAY HAVE BEEN APPLYING SIGNIFICANT PRESSURE DURING SURGERY. THE SKIN ON THE UPPER ARM WHERE THE CUFF WAS PLACED APPEARED LIGHT RED AND SHINY; HOWEVER, BELOW THE CUFF AT APPROXIMATELY THE ELBOW CREASE, THE SKIN WAS DARK RED WITH BLACK AND BLUE AREAS. IT WAS ASSUMED BY THE USER THE CUFF HAD INFLATED AND DID NOT DEFLATE PROPERLY DUE TO A KINKED HOSE, CAUSING PRESSURE TO BE APPLIED TO THE PATIENT'S ARM FOR SEVERAL HOURS.

  Patient problems: Bruise/Contusion

  MAUDE report 21773140 ↗