CPS Courier™ Guidewire (REF DS2G002)Recalls & reported problems
St. Jude Medical, Inc. · Guidewire, medium · Class 2
Data updated Oct 16, 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 05414734505161), received between Feb 11, 2025 and Mar 7, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance2
- Material Split, Cut or Torn1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2025Difficult to Advance; Difficult to Advance
WHILE IMPLANTATION THE COURIER GUIDWIRE MEDIUM WAS DAMAGED. A PEACE OF THE TIP WAS STUCK IN THE VEIN. LUCKILY WE COULD MOVE THIS OUT.
Patient problems: Insufficient Information
MAUDE report 21544645 ↗MalfunctionFeb 11, 2025Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn
INITIAL CRT IMPLANTATION. AFTER PLACING THE LV LEAD IN THE TARGET VEIN, IT WAS NO MORE POSSIBLE TO PUT THE WIRE OUT OF THE LEAD. THE WIRE IS TORN OFF AND GOT STUCK IN THE ELECTRODE AT THE UPPER END. THE LEAD WAS REPLACED. GOOD MEASUREMENTS. NO PATIENT COMPLICATIONS. STABLE PATIENT
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21353965 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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