Medline MDS1001CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00888277629656), received between Sep 8, 2026 and Sep 30, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (22 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 16, 2026.

Recalls naming this device

1. Aug 30, 2024Open, Classified

   It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.

   Z-0032-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955047 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949038 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948366 ↗
• MalfunctionSep 30, 2026Unable to Obtain Readings; Failure to Deflate

  It was reported that "CUFF PUMPS UP AND THEN CUFF DOES NOT DEFLATE. AFTER IT PUMPS UP IT DOES NOT DO ANYTHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947037 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Display or Visual Feedback Problem

  It was reported that the device was "returned by the customer as not functioning"; "the motherboard is not working just as the one before"; and "We saw an error message on the screen which is a \" 3+ \"."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946713 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Electrical /Electronic Property Problem; Unable to Obtain Readings

  It was reported that "Blood Pressure machine # MDS1001 that was returned by the customer as not functioning. Our technician checked and advised that the motherboard is not working just as the one before. We saw an error message on the screen which is a " 3+ "."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946390 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the blood pressure monitor is giving them inaccurate readings. customer states that the readings are fluctuating.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945476 ↗
• MalfunctionSep 29, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939782 ↗
• MalfunctionSep 29, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938328 ↗
• MalfunctionSep 29, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934173 ↗
• MalfunctionSep 29, 2026Unable to Obtain Readings; High Readings; Low Readings

  It was reported that when using the cuff the reading will be really high then ER2 will show right after then she will try again it and it'll show a very low reading then ER2 error will show again. This has been happening on a regular basis at one point it showed ERR and wouldn't read.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934034 ↗
• MalfunctionSep 29, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932311 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923196 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920797 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918100 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that 2 of the cuffs we ordered have stopped working properly and are not giving accurate readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918091 ↗
• MalfunctionSep 28, 2026Unable to Obtain Readings; Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916920 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "The monitor is providing inconsistent and inaccurate readings."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915832 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  It was reported that "Numbers go up and down. It over inflates - extreme pressure on my arm where I have to press the stop button."

  Patient problems: Discomfort

  MAUDE report 50913444 ↗
• MalfunctionSep 24, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889730 ↗
• MalfunctionSep 24, 2026Computer Software Problem; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885631 ↗
• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "2 of the cuffs we ordered have stopped working properly and are not giving accurate readings."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885335 ↗
• OtherSep 24, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "DIGITAL BLOOD PRESSURE IS READING UP AND DOWN AND NOT GIVING A READING ACCURACY. TRIED TO LEAVE ON LONGER AND ADJUSTED THE CUFF BUT STILL NOT WORKING. DOES NOT SHOW NO ERROR CODE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884940 ↗
• MalfunctionSep 24, 2026Overheating of Device; Battery Problem

  It was reported that "SHE CHANGED BP BATTERIES AND NOW IT DOESNT WORK AND ITS JUST GETTING HOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884383 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  It was reported that "HE CAN HEAR A HISSING SOUND COMING FROM THE CUFF AND NOT GETTING ACCURATE READING. THERE IS AN ERROR MESSAGE COMING FROM THE MACHINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884040 ↗