N/A 60-7600-005-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · ZIMMER® A.T.S. CYCLINDRICAL TOURNIQUET CUFF, SINGLE PORT, SINGLE BLADDER 30 in. 76 cm) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024377790), received between Mar 1, 2022 and Jan 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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.
Most reported problems
Device problems
- Gas/Air Leak2
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2023Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak
IT WAS REPORTED THAT DURING SURGERY, THE PRODUCT HAD AIR LEAKAGE. THERE WAS A 0-15 MINUTE DELAY IN SURGERY TO PREPARE AN ALTERNATE PRODUCT. THERE WAS NO NOTED ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION. DUE DILIGENCE IS IN PROGRESS AND THERE HAS BEEN NO RESPONSE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE COMPLETED AND SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16087058 ↗MalfunctionMar 1, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THE CYLINDRICAL CUFF LEAK. THE EVENT TIMING WAS BEFORE SURGERY. THERE WAS NO HARM TO DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13637880 ↗
Other Tourniquet, Pneumatic devices
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- Color Cuff 5921018135Stryker Corporation · TOURNIQUET, PNEUMATIC2 recalls31 reports
- 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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