A.T.S.® Personalized Pressure® 60-4000-101-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00889024376731), received between Apr 22, 2020 and Mar 7, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Measurement System Incompatibility” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K123553); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Measurement System Incompatibility; Measurement System Incompatibility

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547829 ↗
• MalfunctionJan 24, 2025Battery Problem; Measurement System Incompatibility; Battery Problem; Measurement System Incompatibility

  IT WAS REPORTED THAT E17 ERROR, LOW BATTERY ALERT AND OBSERVED -6 MMHG AT 475 MMHG AND 600 MMHG DURING CALIBRATION VERIFICATION. THE PRESSURE DID NOT VARY WITHIN THE RANGE. THE EVENT TIMING WAS DURING CALIBRATION, OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. IT WAS ATTEMPTED TO CALIBRATE THIS UNIT AT THE RECOMMENDED SETPOINTS BUT OBSERVED -6 MMHG AT 475 MMHG AND 600 MMHG WHICH FALLS OUTSIDE SPECIFICATIONS. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229945 ↗
• MalfunctionOct 1, 2024Calibration Problem; Measurement System Incompatibility; Calibration Problem; Measurement System Incompatibility

  IT WAS REPORTED THAT BEFORE SURGERY, THE UNIT HAD A CALIBRATION ERROR UPON POWER UP. WHEN CALIBRATION WAS ATTEMPTED AT 475-MMHG, THE MAIN TRANSDUCER READ ONLY 460-MMHG. THE 475-MMHG PRESSURE WAS NOT ACCEPTED AND THE 475 WAS RED. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343160 ↗
• MalfunctionAug 23, 2024Measurement System Incompatibility; Measurement System Incompatibility

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047898 ↗
• MalfunctionMay 8, 2024Measurement System Incompatibility; Measurement System Incompatibility

  DURING THE CALIBRATION PROCESS, THEY APPLIED PRESSURE TO THE ATS, HOWEVER THE PRESSURE SOURCE WAS FULLY COMPRESSED WITH LITTLE TO NO BACK PRESSURE FROM THE ATS. THE DEVICE PASSES CALIBRATION ON THE BLUE SIDE (CUFF SIDE), HOWEVER GOING DOWN THE RED SIDE (RESERVOIR SIDE), THE MULTIPLE SYRINGES THAT THEY USED AS A PRESSURE SOURCE WERE NOT HOLDING PRESSURE ON THE 250 TEST OR MORE. THE PRESSURE SETTING DID NOT MATCH THE ACTUAL PRESSURE IT WAS SET TO. THE PRESSURE WAS SET TO 250 MMHG. THE ACTUAL PRESSURE READING ON THE DEVICE WAS 60 MMHG. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269932 ↗
• MalfunctionMay 8, 2024Measurement System Incompatibility; Measurement System Incompatibility

  THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269756 ↗
• MalfunctionApr 23, 2024Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING TESTING, THE DEVICE FAILED PM ATTEMPT ON RESERVOIR SIDE (PRESSURE TEST). THE PRESSURE SETTING DID NOT MATCH THE ACTUAL PRESSURE IT WAS SET TO. THERE WAS NO PATIENT INVOLVEMENT. DURING THE CALIBRATION PROCESS THEY APPLIED PRESSURE TO THE ATS, HOWEVER THE PRESSURE SOURCE WAS FULLY COMPRESSED WITH LITTLE TO NO BACK PRESSURE FROM THE ATS. THE DEVICE PASSED CALIBRATION ON THE BLUE SIDE (CUFF SIDE), HOWEVER GOING DOWN THE RED SIDE (RESERVOIR SIDE), THE MULTIPLE SYRINGES THAT THEY USED AS A PRESSURE SOURCE WERE NOT HOLDING PRESSURE ON THE 250 TEST OR MORE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163320 ↗
• MalfunctionJan 23, 2024Measurement System Incompatibility; Pressure Problem; Measurement System Incompatibility; Pressure Problem

  IT WAS REPORTED THAT DURING SURGERY THE MAIN CUFF (RED) WAS SET TO 250MMHG AND WITHIN 1.5 MINUTES THE PRESSURE KEPT GOING UP AND WENT TO 350MMHG. ALARMING HIGH PRESSURE AND HIGH-PRESSURE ERROR. THE SECOND CUFF WAS OKAY. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO SURGICAL DELAY REPORTED. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565944 ↗
• MalfunctionNov 8, 2023Calibration Problem; Measurement System Incompatibility; Pressure Problem; Calibration Problem; Measurement System Incompatibility; Pressure Problem

  UPON REASSESSMENT, THIS FAILURE MODE WAS IDENTIFIED TO NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF IT WERE TO REOCCUR AND THUS SHOULD NOT BE CONSIDERED A REPORTABLE EVENT. PLEASE CONSIDER THE PREVIOUS REPORT VOID. THIS EVENT WAS REPORTED ON MFR-0001526350-2023-01477 NOV 08, 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094027 ↗
• MalfunctionMar 28, 2023Incorrect Measurement; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power; Incorrect Measurement; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power

  THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628937 ↗
• MalfunctionMar 28, 2023Incorrect Measurement; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power; Incorrect Measurement; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power

  THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628917 ↗
• MalfunctionJan 20, 2023Material Frayed; Material Deformation; Material Frayed; Material Deformation

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214240 ↗
• MalfunctionSep 9, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE WAS NO LONGER HOLDING PRESSURE. HOWEVER; THE READING ON THE MACHINE SHOWED IT WAS. THE PRESSURE READING REMAINED AT 250MMHG. THE EVENT TIMING WAS DURING SURGERY AND THERE WAS NO HARM OR DELAY REPORTED. TOWARDS THE END OF THE CASE, THE TOE STARTED TO PINK UP AND BLEED. NO OTHER PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391146 ↗
• MalfunctionSep 1, 2022Break; Material Frayed; Device Fell; Break; Material Frayed; Device Fell

  IT WAS REPORTED THAT BEFORE SURGERY THE DEVICE WAS DROPPED. THE LCD DETACHED AND THE CABLE SEVERED. THERE WERE EXPOSED WIRES DUE TO THE SEVERED CORD. NO HARM OR DELAY WAS REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335906 ↗
• MalfunctionAug 18, 2022Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DEVICE FAILED LEAK TEST. THERE WAS SPONTANEOUS DEFLATION DURING A LEAK TEST THAT WAS PERFORMED DURING PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254363 ↗
• MalfunctionJul 25, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE TOURNIQUET UNIT WOULD INFLATE AND THEN DEFLATE DURING A PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092771 ↗
• MalfunctionApr 18, 2022Calibration Problem; Output Problem; Pressure Problem; Calibration Problem; Output Problem; Pressure Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY THE DEVICE HAD CALIBRATION ISSUES. ONCE IN SURGERY THE DEVICE WAS NOTED TO HAVE DIFFERENT READINGS AND PRESSURE WAS BELIEVED TO BE TOO HIGH. NO HARM OR DELAY WERE REPORTED ALONG WITH THIS EVENT. NO OTHER ADVERSE EVENTS WERE REPORTED ALONG WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138029 ↗
• MalfunctionApr 18, 2022Calibration Problem; Output Problem; Pressure Problem; Calibration Problem; Output Problem; Pressure Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY THE DEVICE HAD CALIBRATION ISSUES. ONCE IN SURGERY THE PRESSURE READINGS WERE DIFFERENT, AND THE PRESSURE WAS TOO HIGH. AT THE BEGINNING OF THE SURGERY THEY INFLATED THE TOURNIQUET. WHEN THE SURGEON MADE HIS INCISION, THERE WAS BLOOD. HE DID THE SURGERY ANYWAY BUT THE VISIBILITY WAS POOR. THERE WAS NO ADDITIONAL PROCEDURE, NO HARM, AND NO DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138013 ↗
• MalfunctionApr 22, 2020Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Pressure Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Pressure Problem

  IT WAS REPORTED THAT THE ATS4000 WAS NEED OF REPAIR FOR CANNOT STOP BLOOD FLOW. EVENT OCCURRED DURING SURGERY; NO HARM AND NO DELAY REPORTED. DURING THE INVESTIGATION, IT WAS FOUND THAT THE LOP WAS GIVING INCORRECT PRESSURE READINGS TO THE USER. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123553. One submission often covers many models, so check the product and lot details in each record.

• Z-0612-2018 · Jul 27, 2017 · Terminated
  A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgic