A.T.S.® Personalized Pressure® 60-2200-301-06Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 1
All models of A.T.S. Personalized Pressure (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024419889), received between Apr 19, 2022 and May 23, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Measurement System Incompatibility” (2 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.
Reports received per month
Most reported problems
Device problems
- Measurement System Incompatibility2
- Deflation Problem1
- Inflation Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionApr 19, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
IT WAS REPORTED THAT BEFORE THE PROCEDURE THE DEVICE WAS INFLATING AND DEFLATING FOR NO REASON. NO HARM OR DELAY WERE NOTED AND ANOTHER DEVICE WAS NOT NOTED TO BE USED. NO OTHER ADVERSE EVENTS WERE REPORTED ALONG WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14140582 ↗
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- A.T.S.® Personalized Pressure® 60320010100Zimmer Orthopaedic Surgical Products, Inc. · TOURNIQUET, PNEUMATIC1 recall20 reports
- Color Cuff 5921-034-135NSStryker Corporation · TOURNIQUET, PNEUMATIC1 recall20 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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