N/A (REF 5921-030-235)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Tourniquet Color Cuff Dual Port, Single Bladder (Royal Blue) Quick Connect · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker Color Cuff dual-port tourniquet cuff is a disposable inflatable band used to limit blood flow during surgery. The 38 reports all describe the cuff leaking air or losing pressure during use, sometimes from loose O-rings or tearing fabric at the connection; no deaths or injuries were reported. One open recall, started in March 2023, cites cuffs that fail to reach or hold the desired pressure because of fabric tears and pinched or unseated O-rings at the connections.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00885825016166), received between Jun 30, 2021 and Oct 30, 2023 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (38 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/Splash38
Patient problems
- No Clinical Signs, Symptoms or Conditions38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS DEFECTIVE AS IT HAD AN AIR LEAK. 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 18031366 ↗MalfunctionAug 4, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE STARTED LEAKING AT THE CONNECTORS WHILE ON A PATIENT DURING A CASE. 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 17465248 ↗MalfunctionJun 22, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17187672 ↗MalfunctionJun 22, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17187630 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16738769 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16738764 ↗MalfunctionApr 6, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE RUBBER O-RINGS WERE LOOSE, AIR WAS AUDIBLY LEAKING FROM THE CONNECTION POINT, AND THE DEVICE PUMP WAS BEEPING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING EXTENDED PROCEDURE TIME. NO INFORMATION WAS PROVIDED, HOWEVER, THERE WAS NO EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16689609 ↗MalfunctionApr 6, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE RUBBER O-RINGS WERE LOOSE, AIR WAS AUDIBLY LEAKING FROM THE CONNECTION POINT, AND THE DEVICE PUMP WAS BEEPING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING EXTENDED PROCEDURE TIME. NO INFORMATION WAS PROVIDED, HOWEVER, THERE WAS NO EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16689603 ↗MalfunctionApr 5, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE LEAKED AND COULD NOT MAINTAIN PRESSURE. 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 16686288 ↗MalfunctionMar 31, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT INFLATE DUE TO A LARGE TEAR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS THREE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16659970 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED CUFF NOT HOLDING PRESSURE AND LEAKING DURING CASE WHILE LIMB WAS MANIPULATED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16652098 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF LEAKED DURING A CASE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640707 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS WOULDN'T INFLATE WHEN CONNECTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640706 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF WILL NOT HOLD INFLATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640705 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF WILL NOT HOLD INFLATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640703 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS LEAKING THROUGHOUT THE ENTIRE CASE AND THE NURSE WAS QUIETING NOISE ON THE PUMP MACHINE DURING THE 35 MINUTES OF DEVICE INFLATION TIME. 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 16640271 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS WOULDN'T INFLATE WHEN CONNECTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640110 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS WOULDN'T INFLATE WHEN CONNECTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640102 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF WILL NOT HOLD INFLATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640033 ↗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 16630650 ↗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 16629948 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF WOULD NOT HOLD INFLATION OR PRESSURE DURING THE PROCEDURE, FLUCTUATING BY 5-10 MM UP AND DOWN. THE O-RING IS SLIPPING OUT OF PLACE ONCE CONNECTED TO THE SMART PUMP'S BLACK TUBING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625027 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF WOULD NOT HOLD INFLATION OR PRESSURE DURING THE PROCEDURE, FLUCTUATING BY 5-10 MM UP AND DOWN. THE O-RING IS SLIPPING OUT OF PLACE ONCE CONNECTED TO THE SMART PUMP'S BLACK TUBING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625025 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF WOULD NOT HOLD INFLATION OR PRESSURE DURING THE PROCEDURE, FLUCTUATING BY 5-10 MM UP AND DOWN. THE O-RING IS SLIPPING OUT OF PLACE ONCE CONNECTED TO THE SMART PUMP'S BLACK TUBING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624993 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE TOURNIQUET CUFF LEAK WOULD NOT FILL WITH AIR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624938 ↗
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- 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
- N/AStryker Sustainability Solutions, 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.