A.T.S. Personalized PressureRecalls & reported problems across all models
Zimmer Orthopaedic Surgical Products, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one A.T.S. Personalized Pressure model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 10 models of A.T.S. Personalized Pressure by Zimmer Orthopaedic Surgical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2020 and Nov 19, 2025 — classified as 2 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Measurement System Incompatibility” (32 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
A.T.S. Personalized Pressure recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 24, 2025Open, 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 ↗
- Dec 24, 2025Open, 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 A.T.S. Personalized Pressure problems
Device problems
- Measurement System Incompatibility32
- Pressure Problem18
- Deflation Problem10
- Gas/Air Leak6
- Output Problem5
- Application Program Version or Upgrade Problem4
- Calibration Problem4
- Device Alarm System4
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- Insufficient Information4
- Blister2
- Bruise/Contusion1
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
A.T.S. Personalized Pressure models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- A.T.S.® Personalized Pressure® 60320010100TOURNIQUET, PNEUMATIC1 recall20 reports
- A.T.S.® Personalized Pressure® 60-5000-101-00TOURNIQUET, PNEUMATIC1 recall5 reports
- A.T.S.® Personalized Pressure® 60-4000-101-00TOURNIQUET, PNEUMATIC19 reports
- A.T.S.® Personalized Pressure® 60-2200-101-00Tourniquet, Pneumatic6 reports
- A.T.S.® Personalized Pressure® 60-2200-301-06TOURNIQUET, PNEUMATIC3 reports
- A.T.S.® Personalized Pressure® 60-2200-301-08TOURNIQUET, PNEUMATIC2 reports
- A.T.S.® Personalized Pressure® 60-2200-301-13TOURNIQUET, PNEUMATIC2 reports
- A.T.S.® Personalized Pressure® 60-4000-301-09TOURNIQUET, PNEUMATIC2 reports
- A.T.S.® Personalized Pressure® 60-2200-301-01TOURNIQUET, PNEUMATIC1 report
- A.T.S.® Personalized Pressure® 60-4000-301-08TOURNIQUET, PNEUMATIC1 report
Recent A.T.S. Personalized Pressure adverse event reports
The 15 most recent reports across all models, 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 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 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 ↗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 ↗MalfunctionMay 23, 2025Measurement System Incompatibility; Measurement System Incompatibility
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE PRESSURE DOES NOT REACH THE DESIRED VALUE AND IS UNSTABLE. WHEN THE PRESSURE IS SET TO 300, THE VALUES DISPLAYED OSCILLATE WITHOUT EVER REACHING THE REQUIRED LEVEL. THIS MALFUNCTION PERSISTS REGARDLESS OF THE CUFF OR CABLE USED. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22078386 ↗MalfunctionMay 23, 2025Measurement System Incompatibility; Measurement System Incompatibility
IT WAS REPORTED DURING AN UNKNOWN EVENT TIMING THAT THE PRESSURE DOES NOT REACH DESIRED VALUE AND IS UNSTABLE. WHEN THE PRESSURE WAS SET TO 300, THE VALUES DISPLAYED OSCILLATE WITHOUT EVER REACHING THE REQUIRED LEVEL. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22078081 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING SURGERY, A PATIENT DEVELOPED BLISTERS. TOPICAL MEDICATION WAS PRESCRIBED BY DERMATOLOGY AND SURGICAL REMOVAL OF THE INFLAMED AREA AND SUTURING WERE PERFORMED. THERE WAS PATIENT IMPACT BUT NO DELAY, HIS SYMPTOMS HAD COMPLETELY CURED. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blister
MAUDE report 21969515 ↗InjuryApr 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT DURING SURGERY, A PATIENT DEVELOPED BLISTERS. TOPICAL MEDICATION WAS PRESCRIBED BY DERMATOLOGY AND SURGICAL REMOVAL OF THE INFLAMED AREA AND SUTURING WERE PERFORMED. THERE WAS PATIENT IMPACT BUT NO DELAY, THE SYMPTOM COMPLETELY CURED. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blister
MAUDE report 21882364 ↗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 ↗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 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 ↗
Other Zimmer Orthopaedic Surgical Products, Inc. products
All Zimmer Orthopaedic Surgical Products, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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