Medline MDS3001Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10080196525140), received between Apr 23, 2019 and Sep 30, 2026 — classified as 1 injury, 45 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952803 ↗
• MalfunctionSep 30, 2026Unable to Obtain Readings; Date/Time-Related Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952398 ↗
• MalfunctionSep 30, 2026Computer Software Problem

  It was reported that "MONITOR DOES NOT INFLATE CUFF AT ALL AND THEN SAYS ER 4."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947850 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  It was reported that "WHEN THE CUFF INFLATES IT WILL GO UP TO 45-65 AND THEN SHUT OFF. CST IS NOT GETTING ANY ERRORS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945858 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937939 ↗
• MalfunctionSep 29, 2026Unable to Obtain Readings

  The report states, "The blood pressure unit itself is not displaying the numbers when in use of taking members blood pressure."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935379 ↗
• MalfunctionSep 29, 2026High Readings; Failure to Shut Off

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933851 ↗
• MalfunctionSep 29, 2026High Readings

  It was reported that "THIS ITEM READS 15% HIGHER THEN AT HIS DOCTORS OFFICE READING IS" and "THIS ITEM IS NOT READING THE SAME AS THE DOCTORS OFFICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930763 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923995 ↗
• MalfunctionSep 28, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922513 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918525 ↗
• OtherSep 28, 2026High Readings; Low Readings

  It was reported that "the blood pressure monitor is off. Clinic informed its off by 20 points. The clinic tested her and noiced it was off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918174 ↗
• MalfunctionSep 28, 2026Incorrect Measurement; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916033 ↗
• MalfunctionSep 25, 2026Computer Software Problem

  It was reported that "GETTING ERROR MSG 4, AND IT IS NOT WORKING.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899950 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "ITEM IS NOT ACCURATE EVEN AFTER REPLACING BATTERIES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897826 ↗
• MalfunctionSep 24, 2026Computer Software Problem

  It was reported that "ITS BRINGING UP ERROR 4" and "NOW IT DOESNT SEEM TO WORK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888986 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  It was reported that when the cuff is hooked up to the BP Monitor, it does not work. As soon as he pulls the tubing out of the monitor, it turns on & makes a sound like it is attempting to inflate but does not.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885888 ↗
• MalfunctionSep 24, 2026High Readings

  It was reported that "THEY HAVE 2 BLOOD PRESSURE MDS3001 AND MDS3001PLUS AND BOTH ARE GIVING THEM EXTREMELY HIGH READING. PT STATED THEY HAD HIGH READING IN THE 200/96..."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884752 ↗
• MalfunctionSep 24, 2026Inflation Problem; Gas/Air Leak

  It was reported that BLOOD PRESSURE IS NOT WORKING PROPERLY, CUFF IS NOT INFATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884418 ↗
• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884355 ↗
• MalfunctionSep 24, 2026Incorrect Measurement

  It was reported that the item was "defective" and "it was more than 40 points off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881909 ↗
• MalfunctionSep 23, 2026Low Readings

  It was reported that BP MONITOR WAS GIVING INACCURATE READINGS AND NEEDED TO BE RECALIBRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871580 ↗
• MalfunctionSep 23, 2026Gas/Air Leak

  It was reported that "There air leak in the hose near cuff. She found a hole where the hose inserts into the cuff."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869423 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "THE READING WERE WAY OFF WHEN COMPARING IT WITH MDO OFFICE READINGS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863233 ↗
• MalfunctionSep 22, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857544 ↗