NA 5920000206Recalls & reported problems
Stryker Corporation · Non-Sterile Fill Line, Set, Quick Connect to Quick Connect · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154599141), received between Jun 1, 2023 and Jan 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (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. 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 Pressure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2025Decrease in Pressure; Decrease in Pressure
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21200733 ↗MalfunctionJun 1, 2023Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THE DEVICE O-RING WAS FALLING OFF OF THE FILL LINES AND APPEARED TO BE TOO TIGHT TO QUICK CONNECT TO SMARTMPUMP DURING TESTING FOR 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 17039487 ↗
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- 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
- 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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