A.T.S.® Personalized Pressure® 60-5000-101-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024626454), received between Aug 15, 2022 and Oct 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Measurement System Incompatibility” (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. Dec 24, 2025Class IIOpen, Classified

   Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

   Z-1201-2026 · 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.

• MalfunctionOct 8, 2024Measurement System Incompatibility; Pressure Problem; Measurement System Incompatibility; Pressure Problem

  THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396384 ↗
• MalfunctionMay 28, 2024Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING SURGERY THAT THE UNIT WAS NOT MAINTAINING PRESSURE. THERE WAS NO HARM OR INJURY AND NO REPORTED DELAY. DUE DILIGENCE IS IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19406226 ↗
• MalfunctionMay 28, 2024Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING SURGERY THAT THE UNIT WAS NOT MAINTAINING PRESSURE. THERE WAS NO HARM OR INJURY TO PATIENT AND NO REPORTED DELAY. DUE DILIGENCE IS IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19405975 ↗
• MalfunctionSep 30, 2022Deflation Problem; Display or Visual Feedback Problem; Deflation Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SURGERY THE UNIT EXPERIENCED SPONTANEOUS DEFLATION OF TOURNIQUET CUFF AND DISPLAY KEPT FLUCTUATING. NO HARM OR DELAY WERE REPORTED AS IT RELATES TO THIS EVENT. NO ADVERSE EVENTS WERE REPORTED AS IT RELATES TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509891 ↗
• MalfunctionAug 15, 2022Deflation Problem; Stretched; Detachment of Device or Device Component; Gas/Air Leak; Deflation Problem; Stretched; Detachment of Device or Device Component; Gas/Air Leak

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS A DEMO UNIT THAT WAS IN NEED OF REPAIR AS THE VALVE ASSEMBLY, MAIN CUFF, AND THE DEFLATE VALVE FOR THE SECONDARY CUFF WERE LEAKING AIR. THE MAIN TUBING WAS FALLING APART AND THE TUBING WAS LEAKING AIR AS WELL DUE TO BEING STRETCHED OUT. THE BARB FITTING FOR THE MAIN CUFF WAS ALSO ADJUSTED DUE TO AN AIR LEAK. THERE WAS ALSO SPONTANEOUS DEFLATION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223621 ↗