N/A 60-7070-106-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH PLC, DUAL PORT, SINGLE BLADDER, 34 IN. (86 CM) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024377134), received between Sep 30, 2021 and Dec 10, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (6 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 Problem6
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 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 20893937 ↗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 20893807 ↗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 20893701 ↗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 20893462 ↗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 20892925 ↗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 20892771 ↗MalfunctionSep 30, 2021Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE TOURNIQUET IS NOT HOLDING PRESSURE. THE EVENT TIMING IS UNKNOWN. THERE WAS NO HARM. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12555714 ↗
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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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