N/A (REF 5921-218-235)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Tourniquet Color Cuff Dual Port, Single Bladder (Red), Quick Connect · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885825016296), received between Mar 23, 2023 and May 20, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (20 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Mar 1, 2023Open, Classified
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
Z-1315-2023 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Leak/Splash20
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information2
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Material Fragmentation; Leak/Splash; Material Integrity Problem
IT WAS REPORTED THE CUFF WOULD NOT INFLATE, HAD TO REMOVE AND USE ANOTHER ONE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25235293 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS LEAKING. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16644035 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE DID NOT INFLATE PROPERLY. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16639884 ↗MalfunctionMar 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED VARIOUS SIZES OF TOURNIQUET CUFFS DEVICES WERE LEAKING AIR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16630703 ↗MalfunctionMar 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED VARIOUS SIZES OF TOURNIQUET CUFFS DEVICES WERE LEAKING AIR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16630348 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624937 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624932 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624931 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE TOURNIQUET CUFF HAD A HOLE AND DID NOT INFLATE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624881 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624879 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624877 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624874 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624826 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE TOURNIQUET CUFF HAD A HOLE AND DID NOT INFLATE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624824 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624822 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624820 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF DEVICE NOT HOLDING PRESSURE DURING PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624775 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE TOURNIQUET CUFF HAD A HOLE AND DID NOT INFLATE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624743 ↗MalfunctionMar 24, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT INFLATING CORRECTLY. IT WAS SET TO 250 BUT IT WOULD RISE TO 300 AND THEN DROP. THE MACHINE ALARMED. THE DEVICE WAS REPLACED WITH ANOTHER FROM THE SAME LOT WHICH FUNCTIONED PROPERLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME WAS 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16613506 ↗MalfunctionMar 23, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS LEAKING, WOULDN'T HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16598738 ↗
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
- Color Cuff 5921-034-135NSStryker Corporation · TOURNIQUET, PNEUMATIC1 recall20 reports
- A.T.S.® Personalized Pressure® 60320010100Zimmer Orthopaedic Surgical Products, Inc. · TOURNIQUET, PNEUMATIC1 recall20 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.