A.T.S.® Personalized Pressure® 60-2200-101-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024376540), received between Oct 27, 2022 and Aug 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Measurement System Incompatibility” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING KIT INSPECTION THE DEVICE DID NOT HOLD PRESSURE. DEVICE WAS SET TO 250MMHG; HOWEVER, THE DEVICE IS READING BETWEEN 230 TO 320MMHG. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916485 ↗
• MalfunctionAug 12, 2025Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE UNIT STRUGGLED TO MAINTAIN PRESSURE AND WAS CONSTANTLY MAKING THE INFLATING NOISE. IT WAS SET TO 250MMHG, INFLATE AND THE MACHINE WOULD HOVER BETWEEN 240-249MMHG BUT WITH A CONTINUOUS SOUND OF INFLATING. IT APPEARED TO BE WORKING HARD TO MAINTAIN THE PRESSURE. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22782321 ↗
• MalfunctionApr 4, 2024Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE PRESSURE ON THE DEVICE WAS NOT MAINTAINING THE PRESSURE IT WAS SET TO AT THE BEGINNING OF THE CASE. THERE WAS NO SURGICAL DELAY. DOCTORS WERE SEEING PATIENTS COMING BACK WITH SEVERE BRUISING FROM THE TOURNIQUET. THE PA STARTED NOTICING THAT THIS PROBLEM WAS ONLY OCCURRING WITH THIS SPECIFIC MACHINE. DUE DILIGENCE IS IN PROGRESS, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bruise/Contusion

  MAUDE report 19045253 ↗
• MalfunctionDec 4, 2023Use of Incorrect Control/Treatment Settings; Noise, Audible; Use of Incorrect Control/Treatment Settings; Noise, Audible

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS MAKING A PECULIAR NOISE AND THE PRESSURE SENSOR IS CONSTANTLY ACTIVE CALCULATING THE PRESSURE OCCURRING FROM BOTH PORTS. THERE WAS NO PATIENT IMPACT OR DELAY. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255448 ↗
• MalfunctionDec 19, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED DURING INSPECTION/TESTING, THE DEVICE SPONTANEOUSLY DEFLATED AND REQUIRED UNKNOWN REPAIRS. NO ADVERSE EVENT WAS REPORTED AS IT RELATES TO THE EVENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010069 ↗
• MalfunctionOct 27, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PM, THE PRESSURE GIVEN OUT IS 10-13 MMHG MORE THAN WHAT IT WAS SET TO. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15682588 ↗