Shepherd PSP14S-30006Recalls & reported problems
Cardiovascular Systems, Inc. · 0.014" Shepherd ES Guidewire - straight 300 cm - 6 gms · Class 2
- 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 10850026568582), received between Oct 25, 2022 and Oct 25, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Advance1
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.
MalfunctionOct 25, 2022Difficult to Advance; Difficult to Advance
A SHEPHERD .014 GUIDE WIRE WAS ADVANCED IN A CHRONIC TOTAL OCCLUSION (CTO) IN THE MID POSTERIOR TIBIAL (PT) ARTERY. THE USER USED FORCE TO ADVANCE THE GUIDE WIRE WHEN IT PERFORATED THE PT. AN UNSUCCESSFUL ATTEMPT TO ADVANCE THROUGH THE CTO WAS THEN MADE USING A NON-CSI GUIDE WIRE. NO INTERVENTION WAS PERFORMED AND THE PATIENT'S CONDITION WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15666245 ↗
Other Wire, Guide, Catheter devices
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.