Color Cuff 5921218135Recalls & reported problems
Stryker Corporation · Disposable Tourniquet Cuff Single Bladder, Single Port and Quick Connect Connector · Class 1
All models of Color Cuff (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613154599738), received between Oct 28, 2019 and Mar 25, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (10 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
- Decrease in Pressure10
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Decrease in Pressure
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY TWO TOURNIQUETS TEARING AT THE SEAMS AND NOT HOLDING PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690660 ↗MalfunctionMay 6, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21967284 ↗MalfunctionMay 6, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21967283 ↗MalfunctionApr 3, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762667 ↗MalfunctionApr 3, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762352 ↗MalfunctionApr 22, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE WAS HAVING ISSUES TO MAINTAINING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154584 ↗MalfunctionApr 22, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE WAS HAVING ISSUES TO MAINTAINING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154577 ↗MalfunctionJan 16, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE WAS LEAKING DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18520340 ↗MalfunctionJan 16, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE WAS LEAKING DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18520331 ↗MalfunctionOct 28, 2019Decrease in Pressure; Decrease in Pressure
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9244426 ↗
Other TOURNIQUET, PNEUMATIC devices
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- 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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