Shepherd PSP18S-30006Recalls & reported problems
Cardiovascular Systems, Inc. · 0.018" Shepherd ES Guidewire - straight 300 cm - 6 gms · Class 2
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 10850026568605), received between Mar 11, 2024 and Mar 11, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2024Difficult to Advance; Difficult to Advance
THE SHEPARD WIRE WAS ADVANCED THROUGH A 018 NAVICROSS CATHETER BUT BECAME STUCK AND COULD NOT BE ADVANCED THROUGH. WHEN REMOVING THE SHEPARD WIRE, THE WIRE COATING WAS DAMAGED AND PEELED OFF. NO COMPONENTS WERE LEFT IN VIVO. A SECOND SHEPARD WIRE WAS USED AND WAS SUCCESSFULLY ADVANCED TO THE SUPERFICIAL FEMORAL ARTERY (SFA). WHEN REMOVING THE SECOND SHEPARD WIRE, IT BECAME STUCK INSIDE THE NAVICROSS CATHETER. BOTH WERE REMOVED TOGETHER. A NEW NAVICROSS CATHETER AND A ASAHI GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE AND DID NOT EXPERIENCE ANY IMPACT FROM THE REPORTED ISSUES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18874930 ↗MalfunctionMar 11, 2024Difficult to Advance; Difficult to Advance
THE SHEPARD WIRE WAS ADVANCED THROUGH A 018 NAVICROSS CATHETER BUT BECAME STUCK AND COULD NOT BE ADVANCED THROUGH. WHEN REMOVING THE SHEPARD WIRE, THE WIRE COATING WAS DAMAGED AND PEELED OFF. NO COMPONENTS WERE LEFT IN VIVO. A SECOND SHEPARD WIRE WAS USED AND WAS SUCCESSFULLY ADVANCED TO THE SUPERFICIAL FEMORAL ARTERY (SFA). WHEN REMOVING THE SECOND SHEPARD WIRE, IT BECAME STUCK INSIDE THE NAVICROSS CATHETER. BOTH WERE REMOVED TOGETHER. A NEW NAVICROSS CATHETER AND A ASAHI GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE AND DID NOT EXPERIENCE ANY IMPACT FROM THE REPORTED ISSUES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18874685 ↗
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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