N/A 60-7070-103-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH PLC, DUAL PORT, SINGLE BLADDER, 18 IN. (46 CM) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024377103), received between Nov 3, 2021 and Dec 10, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (5 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
- Gas/Air Leak5
- Packaging Problem3
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 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 20892362 ↗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 20892286 ↗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 20892246 ↗MalfunctionMar 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED AS PACKAGING WAS CONFORMING AND MET SPECIFICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18876385 ↗MalfunctionOct 25, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE THE CUFF WAS LEAKING AT BOTH CONNECTIONS. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. THERE WAS NO DELAY NOTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15667826 ↗MalfunctionNov 3, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING AIR. THERE WAS NO SPONTANEOUS DEFLATION. THE CUFF WAS UNABLE TO BE USED SO ANOTHER ONE WAS OPENED FOR USE. THE EVENT OCCURRED BEFORE SURGERY. THIS DEVICE WAS BRAND NEW AND JUST REMOVED FROM ITS STERILE PACKAGING. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12745801 ↗MalfunctionNov 3, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING AIR. THERE WAS NO SPONTANEOUS DEFLATION. THE CUFF WAS UNABLE TO BE USED SO ANOTHER ONE WAS OPENED FOR USE. THE EVENT OCCURRED BEFORE SURGERY. THIS DEVICE WAS BRAND NEW AND JUST REMOVED FROM ITS STERILE PACKAGING. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12745793 ↗MalfunctionNov 3, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING AIR. THERE WAS NO SPONTANEOUS DEFLATION. THE CUFF WAS UNABLE TO BE USED SO ANOTHER ONE WAS OPENED FOR USE. THE EVENT OCCURRED BEFORE SURGERY. THIS DEVICE WAS BRAND NEW AND JUST REMOVED FROM ITS STERILE PACKAGING. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12745791 ↗MalfunctionNov 3, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING AIR. THERE WAS NO SPONTANEOUS DEFLATION. THE CUFF WAS UNABLE TO BE USED SO ANOTHER ONE WAS OPENED FOR USE. THE EVENT OCCURRED BEFORE SURGERY. THIS DEVICE WAS BRAND NEW AND JUST REMOVED FROM ITS STERILE PACKAGING. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12745691 ↗
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- A.T.S.® Personalized Pressure® 60320010100Zimmer Orthopaedic Surgical Products, Inc. · TOURNIQUET, PNEUMATIC1 recall20 reports
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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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