A.T.S.® Personalized Pressure® 60320010100Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889024626447), received between Nov 8, 2023 and Nov 19, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Measurement System Incompatibility” (15 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-1202-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Gas/Air Leak; Pressure Problem; Gas/Air Leak; Pressure Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE WAS NOT MAINTAINING PROPER PRESSURE AND IT WAS CONFIRMED THAT THE TOURNIQUET HOSE DID NOT CAUSE A LEAK. THE PRESSURE WAS SET TO 250, THE PRESSURE WAS NOT WITHIN THE ACCEPTABLE RANGE. HOWEVER, ACTUAL READING WAS UNKNOWN. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DURING INVESTIGATION THE PRESSURE WAS FLUCTUATING OUTSIDE SPECIFICATION. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598920 ↗
• MalfunctionOct 30, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY ON AN UNKNOWN DATE, THE DEVICE HAD A PROBLEM THAT HAS BEEN AN ISSUE SINCE ITS PURCHASE, PROBLEM THAT IS NOT SPECIFY IN THIS CMP HOWEVER A CMP HISTORY WAS MADE AND FOUND TWO PROBLEMS: WON'T HOLD PRESSURE AND FLUTTERING LEFT SIDE. BIOMED WAS TOLD A SOFTWARE REPAIR WAS BEING DEVELOPED AND THE REPAIR WOULD COME AFTER. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. AFTER INVESTIGATION IT WAS FOUND THAT THE PRESSURE WAS FLUTTERING OUTSIDE THE ACCEPTABLE RANGE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424088 ↗
• MalfunctionAug 22, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING SURGERY ON THAT THE UNIT DOES NOT MAINTAIN CONSTANT PRESSURE. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO REPORTED DELAY. DUE DILIGENCE IS COMPLETE. AFTER THE INVESTIGATION WAS FOUND THAT THE PRESSURE SETTING DID NOT MATCH ACTUAL PRESSURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872938 ↗
• MalfunctionAug 19, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT AT UNKNOWN TIMING ON AN UNKNOWN DATE THE A.T.S. 3200TS TOURNIQUET HAD A PROBLEM OF NOT MAINTAINING CONSTANT PRESSURE. IT IS UNKNOWN IF HARM OR DELAY OCCURRED. AT INVESTIGATION IT WAS NOTED THAT THE DEVICE VARIED AT 4 OR 5 MMHG IN PRESSURE FROM ITS SET POINT. DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22842671 ↗
• MalfunctionMar 27, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING SURGERY, SECONDARY PORT NOT HOLDING PRESSURE. IT WAS GOING UP 10MMHG AND GOING BACK DOWN AND BACK UP CONSTANTLY. THERE WAS NO PATIENT HARM/INJURY. THERE WAS NO SURGICAL DELAY REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE DEVICE PRESSURE WAS FLUTTERING OUTSIDE OF THE ACCEPTABLE RANGE (10 MMHG) ON THE SECONDARY PORT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707139 ↗
• MalfunctionMar 20, 2025Device Alarm System; Measurement System Incompatibility; Device Alarm System; Measurement System Incompatibility

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE FLUTTERS WHEN USING BLUE SIDE, DOES NOT MAINTAIN CONSISTENT PRESSURE AND THE UNIT WAS ALSO BEEPING. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. THE PRESSURE WAS SET UP AT: 250 MMHG. THE PRESSURE WAS NOT WITHIN THE ACCEPTABLE RANGE FOR THIS UNIT AS THE ACTUAL PRESSURE READING WAS BETWEEN 243 -254MMHG. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657331 ↗
• MalfunctionOct 14, 2024Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem; Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439632 ↗
• MalfunctionOct 10, 2024Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem; Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417495 ↗
• MalfunctionOct 8, 2024Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem; Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT HAD A PRESSURE FLUTTERING ERROR AND NEEDED TO BE RETURNED FOR SERVICING TO UPDATE THE SOFTWARE. THE PRESSURE WAS SET TO 250MMHG, 350MMHG. THE PRESSURE READING FLUCTUATED 15-40MMHG FROM THE SET PRESSURE THROUGHOUT PROCEDURES ON ALL DEVICES. ALL DEVICES WERE PLUGGED IN TO HOSPITAL GRADE OUTLETS DURING USE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. THERE WAS NO MEDICAL INTERVENTION/ADDITIONAL SURGICAL PROCEDURE REQUIRED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401980 ↗
• MalfunctionSep 27, 2024Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem; Application Program Version or Upgrade Problem; Measurement System Incompatibility; Pressure Problem

  IT WAS REPORTED DURING SURGERY THAT THE UNIT HAS THE PRESSURE FLUTTERING ERROR AND NEED TO BE RETURNED TO SERVICE TO UPGRADE THE SOFTWARE. THERE IS NO HARM OR DELAY REPORTED. THE PRESSURE WAS SET TO 250MMHG, 350MMHG. THE PRESSURE READING FLUCTUATED 15-40MMHG FROM THE SET PRESSURE THROUGHOUT PROCEDURES ON ALL DEVICES. ALL DEVICES WERE PLUGGED IN TO HOSPITAL GRADE OUTLETS DURING USE. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321270 ↗
• MalfunctionSep 5, 2024Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE ATS 3200 FLUTTERS WHEN USING BLUE SIDE AND DOES NOT MAINTAIN CONSISTENT PRESSURE. THE PRESSURE SETTING DID NOT MATCH THE ACTUAL PRESSURE IT WAS SET TO. WHEN SET AT 250 IT FLUCTUATED BETWEEN 225-270. THE UNIT FLUCTUATED WHILE INFLATED. THE DEVICE WAS UTILIZING AC WALL POWER (PLUGGED IN) WHEN THE CUSTOMER EXPERIENCED THIS BEHAVIOR. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153880 ↗
• MalfunctionJun 13, 2024Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING SURGERY THAT THE UNIT'S LEFT SIDE PUMPS CONTINUOUSLY; THE UNIT WOULD NOT REMAIN AT STABLE PRESSURE DURING OPERATION. IT MAY STOP FOR A BIT BUT RARELY STOPS INFLATING AND THIS IS WITH MULTIPLE TUBING SETS. THERE WAS NO HARM OR INJURY TO PATIENT. A 5 MINUTE DELAY WAS REPORTED WHILE AN ALTERNATE DEVICE WAS RETRIEVED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528450 ↗
• MalfunctionMay 28, 2024Measurement System Incompatibility; Pressure Problem; Measurement System Incompatibility; Pressure Problem

  IT WAS REPORTED DURING PM THAT BLUE SIDE RUNS CONTINUOUSLY, DOES NOT HOLD STEADY PRESSURE. IT WAS SET TO 250 AND WOULD NOT STAY THERE. IT RAN CONTINUOUSLY (TESTED FOR SEVERAL MINUTES) AND BOUNCED UP AND DOWN TRYING TO MAINTAIN 250. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19411318 ↗
• MalfunctionMay 28, 2024Measurement System Incompatibility; Pressure Problem; Measurement System Incompatibility; Pressure Problem

  IT WAS REPORTED DURING PM THAT THE BLUE SIDE RUNS CONTINUOUSLY, DOES NOT HOLD STEADY PRESSURE, THERE IS NO HARM OR SURGERY. THERE WAS NO SPONTANEOUS DEFLATION. IT WAS SET TO 250 AND WOULD NOT STAY THERE. IT RAN CONTINUOUSLY (TESTED FOR SEVERAL MINUTES) AND BOUNCED UP AND DOWN TRYING TO MAINTAIN 250. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19410578 ↗
• MalfunctionMay 28, 2024Device Alarm System; Measurement System Incompatibility; Device Alarm System; Measurement System Incompatibility

  IT WAS REPORTED THAT THE PRESSURE STILL WAS FLUTTERING AND BEEPING OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19405488 ↗
• MalfunctionApr 16, 2024Measurement System Incompatibility; Measurement System Incompatibility

  THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119472 ↗
• MalfunctionApr 16, 2024Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, WHEN TWO BRAND NEW A.T.S 3200 UNITS WERE POWERED ON AND TOURNIQUET CUFFS ATTACHED, THE PRESSURE FLUTTERED AND COULD NOT ESTABLISH STABILIZED PRESSURE. THEY TRIED SEVERAL CUFFS SAME RESULT. THEY DID A LEAK TEST ON CUFFS, AND THEY DID NOT SHOW A LEAK. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119218 ↗
• MalfunctionApr 11, 2024Computer Software Problem; Measurement System Incompatibility; Computer Software Problem; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING RECEIVING INSPECTION THAT THE UNIT WAS POWERED ON, AND TOURNIQUET CUFFS ATTACHED, THE PRESSURE FLUTTERED AND COULD NOT ESTABLISH STABILIZED PRESSURE. IT WAS SHOWING THE LINE OCCLUSION ERROR WHEN THE LINE WAS NOT OCCLUDED. A LEAK TEST WAS PERFORMED ON THE CUFFS, AND THEY DID NOT SHOW A LEAK. DEVICE WAS SET ON THE DEFAULT SETTING OF 250 MMHG. IF FLUTTERED BETWEEN 245 AND 260 MMHG. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO REPORTED DELAY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088568 ↗
• MalfunctionMar 15, 2024Measurement System Incompatibility; Noise, Audible; Measurement System Incompatibility; Noise, Audible

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE RED SIDE OF THE TOURNIQUET IS FLUCTUATING FROM 150 - 250 MMHG RAPIDLY (INFLATING AND DEFLATING BETWEEN HIGH AND LOW PRESSURES). THE RED PORT WAS ALSO EMITTING A LOUD TICKING NOISE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912332 ↗
• MalfunctionNov 8, 2023Measurement System Incompatibility; Measurement System Incompatibility

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093380 ↗