N/A 60-7070-104-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH PLC, DUAL PORT, SINGLE BLADDER, 24 IN. (61 CM) · Class 1
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 00889024377110), received between Aug 29, 2022 and Dec 10, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (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
- Packaging Problem2
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2024Packaging Problem; Packaging Problem
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED AS THE PACKAGING WAS CONFORMING. THIS MEDWATCH IS BEING VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892515 ↗MalfunctionDec 10, 2024Packaging Problem; Packaging Problem
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED AS THE PACKAGING WAS CONFORMING. THIS MEDWATCH IS BEING VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892472 ↗MalfunctionAug 29, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING THE SURGERY, THE AIR LEAKAGE WAS DETECTED ON THIS COMPLAINT PRODUCT IN THE CUFF. THIS PRODUCT IS DISPOSABLE PRODUCT, SO THIS COMPLAINT PRODUCT WAS UNUSED PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15310459 ↗
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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