A.T.S.® Personalized Pressure® 60-2200-301-01Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024419834), received between Mar 23, 2023 and Mar 23, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
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
Device problems
- Deflation Problem1
- Gas/Air Leak1
- Output Problem1
- Patient Device Interaction Problem1
- Pressure Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2023Deflation Problem; Gas/Air Leak; Output Problem; Pressure Problem; Patient Device Interaction Problem; Deflation Problem; Gas/Air Leak; Output Problem; Pressure Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT DURING SURGERY THE TOURNIQUET HAD AN AIR LEAKAGE AT THE CUFF END INTERFACE. THE MACHINE SHOWED THAT THE PRESSURE IS UNSTABLE, FLUCTUATING UP AND DOWN. THE EQUIPMENT WAS CONSTANTLY REPLENISHED WITH AIR SOURCE, RESULTING IN THE INABILITY TO EFFECTIVELY STOP BLEEDING DURING THE OPERATION. THE SURGICAL FIELD IN THE WOUND IS UNCLEAR, RESULTING IN SLOW OPERATION PROGRESS AND EXCESSIVE BLOOD LOSS IN THE PATIENT'S LIMBS, THE FUNCTION OF THE HEMOSTAT SERVES TO BLOCK THE BLOOD FLOW BETWEEN THE LIMBS AND REDUCE BLEEDING. THE DOCTOR CHOSE TO STICK THE ROOT OF THE FINGER TO REDUCE THE BLEEDING, THE EQUIPMENT WAS IMMEDIATELY STOPPED, AND THE SPARE EQUIPMENT WAS REPLACED TO CONTINUE THE OPERATION. THERE WAS SPONTANEOUS DEFLATION DUE TO THE BAD CONNECTOR. THE AMOUNT OF BLOOD LOST BY THE PATIENT WAS 50CC, HOWEVER THERE WAS NO MEDICAL INTERVENTION OR BLOOD TRANSFUSION PERFORMED. THE PRESSURE OBSERVED WAS LESS THAN THE SET PRESSURE. NO ADVERSE EVENT AS A RESULT TO THE DEVICE MALFUNCTION. DUE DILIGENCE IS COMPLETE AND THERE IS NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16598117 ↗
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- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall72 reports
- Color Cuff 5921018235Stryker Corporation · TOURNIQUET, PNEUMATIC2 recalls20 reports
- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall38 reports
- SmartPump 5920011000Stryker Corporation · TOURNIQUET, PNEUMATIC72 reports
- 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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