A.T.S.® Personalized Pressure® 60-4000-301-09Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024420199), received between Apr 22, 2025 and May 6, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Blister2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
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 · TerminatedA.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
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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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