Shepherd PSP18S-30012Recalls & reported problems
Cardiovascular Systems, Inc. · 0.018" Shepherd ES Guidewire - straight 300 cm - 12 gms · 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 10850026568643), received between Nov 16, 2022 and Nov 16, 2022 — 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.
Most reported problems
Device problems
- Difficult to Advance1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2022Fracture; Difficult to Advance; Fracture; Difficult to Advance
A SHEPHERD GUIDE WIRE WAS INSERTED INTO A 0.035 NAVICROSS 90CM ANGLED CATHETER, ALONG WITH A MONGO GUIDE WIRE IN A SIDE BRANCH FROM A RETROGRADE PEDAL SHEATH IN THE DORSALIS PEDIS ARTERY. ONCE THE SHEPHERD GUIDE WIRE WAS INSERTED AND NAVIGATED INTO A TORTUOUS, DISEASED SUBINTIMAL ARTERIAL SPACE, THE MONGO GUIDE WIRE WAS RETRACTED EX-VIVO WITH SOME RESISTANCE. THE TIP OF THE SHEPHERD GUIDE WIRE WAS BENT DISTAL TO THE RADIOPAQUE PORTION OF THE WIRE. THE PHYSICIAN ATTEMPTED TO PULL THE SHEPHERD GUIDE WIRE OUT OF THE NAVICROSS CATHETER WHEN THE WIRE FRACTURED. THE FRACTURED COMPONENT WAS UNABLE TO BE RETRIEVED AND REMAINED IN SUBINTIMAL SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15804543 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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