CPS Courier™ Guidewire (REF DS2G004)Recalls & reported problems
St. Jude Medical, Inc. · Guidewire, extra-firm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734505185), received between Jun 11, 2025 and Jun 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
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 Advance1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Difficult to Advance; Difficult to Advance
TODAY A COUPLE OF HOURS AFTER A SUCCESSFULLY CRT IMPLANT PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THE GUIDEWIRE USED TO POSITION THE CRT LEAD SUPPOSEDLY PERFORATED THE TARGET VESSEL. THE EFFUSION RESULTED IN A CARDIAC TAMPONADE; SO THE PATIENT UNDERWENT CARDIO-TORACIC SURGERY TO RESOLVE THE ISSUE. DURING THIS PROCEDURE THE QUARTET1456Q CRT LEAD WAS REMOVED AND A NEW EPICARDIC BIPOLAR LEAD WAS IMPLANTED. PATIENT CONDITIONS ARE GOOD AND STABLE.
Patient problems: Perforation of Vessels
MAUDE report 22183552 ↗
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- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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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