N/A (REF 5921-034-135)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Tourniquet Color Cuff Single Port, Single Bladder (Purple), 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 disposable tourniquet cuff is a single-bladder, single-port color cuff used to limit bleeding during surgery. Most of the 72 reports describe the cuff leaking, tearing, or failing to inflate or hold pressure, in a few cases causing blood loss during procedures. There are 6 injuries and no deaths. One recall, started in March 2023, remains open and covers cuffs that cannot reach or hold desired pressure because the fabric tears or the O-ring connection is pinched.
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
- 72
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00885825016173), received between Jan 11, 2017 and Jul 3, 2024 — classified as 6 injuries, 66 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (61 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/Splash61
- Inflation Problem7
- Air Leak3
- Infusion or Flow Problem1
- No Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- No Known Impact Or Consequence To Patient3
- Insufficient Information2
- Blood Loss1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT TOURNIQUET HAD A BIG SLIT IN IT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 35-40 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19670272 ↗MalfunctionJul 3, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TOURNIQUET CUFF DID NOT INFLATE. 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 19669901 ↗MalfunctionNov 22, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS LEAKING. 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 18193868 ↗MalfunctionMay 9, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE RIPPED. 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 16898781 ↗MalfunctionApr 26, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WOULD NOT INFLATE AND WAS REPLACED WITH ANOTHER DEVICE. 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 16818242 ↗MalfunctionApr 18, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS PLACED ON PATIENT PER PROTOCOL BUT IT WAS UNABLE TO INFLATE WHEN THE DOCTOR NEEDED TO START THE SURGICAL PROCEDURE. IT WAS ATTEMPTED TO REPLACE THE TOURNIQUET, TUBING, CORDS, BUT THE DEVICE WAS STILL UNABLE TO INFLATE. THE DOCTOR STARTED SURGERY WITHOUT THE DEVICE AND COMPLAINED OF INCREASED BLEEDING DURING PROCEDURE (300ML). NO TRANSFUSION WAS REQUIRED. IT WAS REPORTED THE PATIENT WAS SENT TO PACU AFTER PROCEDURE WITH NO ISSUES AND NO PATIENT HARM AND THAT NOTHING IN THE CHART GAVE ANY IMPRESSION OF ADVERSE CONSEQUENCES, UNANTICIPATED MEDICAL PROCEDURES, OR ADDITIONAL TREATMENTS. NO DELAY WAS NOTED AND THUS NO SIGNIFICANT NEED FOR ADDED SEDATION/ANESTHESIA. THE PATIENT WAS REPORTED TO HAVE BEEN TRANSFERRED TO RECOVERY IN STABLE CONDITION WITH NO COMPLICATIONS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16763137 ↗MalfunctionApr 18, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS PLACED ON PATIENT PER PROTOCOL BUT IT WAS UNABLE TO INFLATE WHEN THE DOCTOR NEEDED TO START THE SURGICAL PROCEDURE. IT WAS ATTEMPTED TO REPLACE THE TOURNIQUET, TUBING, CORDS, BUT THE DEVICE WAS STILL UNABLE TO INFLATE. THE DOCTOR STARTED SURGERY WITHOUT THE DEVICE AND COMPLAINED OF INCREASED BLEEDING DURING PROCEDURE (300ML). NO TRANSFUSION WAS REQUIRED. IT WAS REPORTED THE PATIENT WAS SENT TO PACU AFTER PROCEDURE WITH NO ISSUES AND NO PATIENT HARM AND THAT NOTHING IN THE CHART GAVE ANY IMPRESSION OF ADVERSE CONSEQUENCES, UNANTICIPATED MEDICAL PROCEDURES, OR ADDITIONAL TREATMENTS. NO DELAY WAS NOTED AND THUS NO SIGNIFICANT NEED FOR ADDED SEDATION/ANESTHESIA. THE PATIENT WAS REPORTED TO HAVE BEEN TRANSFERRED TO RECOVERY IN STABLE CONDITION WITH NO COMPLICATIONS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16763130 ↗MalfunctionApr 11, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE DEVICE LEAKED AND HAD TO BE REPLACED DURING THE PROCEDURE AFTER THE INCISION WAS MADE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE SURGERY WAS DELAYED APPROXIMATELY 20 MINUTES WHILE THE PATIENT WAS RE=DRAPED DUE TO POSSIBLE STERILITY ISSUES AFTER THE LEAK. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716691 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS DEFECTIVE AS THE DISTAL PORT WAS LEAKING AIR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 1-2 MINUTES TO IDENTIFY THE PROBLEM AND REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16651887 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE IS DEFECTIVE, IT WAS LEAKING AND SETTING OFF ALARMS IN THE OR ROOM. 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 16651884 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF DEVICE HAD AN O RING ISSUE, NOT HOLDING AIR. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR THE DURATION OF THE EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16651655 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF DEVICE HAD AN O RING ISSUE, NOT HOLDING AIR. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR THE DURATION OF THE EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16651446 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT HOLDING 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 16651196 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE DEVICE WAS NOT INFLATING ON THE MACHINE. IT WOULD LOSE INFLATION AFTER 10 MINUTES OR SO INTO THE CASE ON MULTIPLE MACHINES. IT WAS RESOLVED WITH DUAL PORT CUFFS (FROM THE SINGLES WHICH DIDN'T WORK) THAT HELD INFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16650142 ↗MalfunctionMar 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE COMPLAINT DEVICE HAD AN ISSUE WITH THE O-RING AND THE STRAP DISCONNECTED. 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 16644040 ↗MalfunctionMar 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF TUBING WAS CRACKED/BROKEN AND WOULD NOT HOLD PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632589 ↗MalfunctionMar 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS DEVICES ARE NOT WORKING AND NOT INFLATING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632586 ↗MalfunctionMar 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE TOURNIQUET CUFF DEVICE WAS LEAKING/NOT HOLDING PRESSURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16631687 ↗MalfunctionMar 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFF NOT WORKING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16630859 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS DEVICES ARE NOT WORKING AND NOT INFLATING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625150 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS DEVICES ARE NOT WORKING AND NOT INFLATING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625136 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS DEVICES ARE NOT WORKING AND NOT INFLATING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625135 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS DEVICES ARE NOT WORKING AND NOT INFLATING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625134 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS DEVICES ARE NOT WORKING AND NOT INFLATING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625132 ↗MalfunctionMar 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET CUFFS DEVICES ARE NOT WORKING AND NOT INFLATING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625131 ↗
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- A.T.S.® Personalized Pressure® 60320010100Zimmer Orthopaedic Surgical Products, Inc. · TOURNIQUET, PNEUMATIC1 recall20 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.