N/A (REF 60-7070-103)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Tourniquet Cuff Dual Port, Single Bladder (Red), PLC · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825013851), received between Nov 8, 2016 and May 10, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Decrease in Pressure1
- Inflation Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2024Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem
IT WAS REPORTED THE DEVICE DID NOT SEAL FULLY DURING ANKLE CASE. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19291729 ↗MalfunctionMar 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TOURNIQUET WOULDN'T INFLATE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16640697 ↗MalfunctionNov 8, 2016Inflation Problem; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE DID NOT INFLATE AND READ LOW PRESSURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6086001 ↗
Other TOURNIQUET, PNEUMATIC devices
- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall82 reports
- 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.