Shepherd PSP18S-30030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10850026568681), received between Aug 3, 2022 and Mar 21, 2023 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  THE SHEPHERD GUIDE WIRE COULD NOT BE ADVANCED THROUGH A CHRONIC TOTAL OCCLUSION (CTO) IN A VERY CALCIFIED ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN ATTEMPTED TO PUSH THE WIRE IN ORDER TO ADVANCE IT THROUGH THE CTO. THE WIRE BECAME STUCK WHEN REMOVING IT FROM THE NON-CSI 0.035 SUPPORT CATHETER AND FRACTURED IN VIVO AT THE RADIOPAQUE TIP. USING A 2.5 MM X 100 MM JADE BALLOON, THE BALLOON WAS DEFLATED WHEN ATTEMPTING TO REMOVE THE FRAGMENT FROM THE VESSEL. THE FRAGMENT WAS EMBEDDED IN THE SUB-MEDIAL PORTION OF THE VESSEL PREVENTING THE USE OF A SNARE. THE FRAGMENT REMAINS IN THE CHRONIC TOTAL OCCLUSION SEGMENT OF THE DISTAL RIGHT AT. THE LESION WAS NOT TREATED, AND THE PROCEDURE WAS COMPLETED. A PROCEDURE IS PLANNED FOR ANOTHER ANGIOGRAM WITH INTERVENTION UTILIZING AN ANTEGRADE APPROACH TO CROSS THE AT. THE PATIENT IS IN REST PAIN PER CRITICAL LIMB ISCHEMIA CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580799 ↗
• MalfunctionDec 6, 2022Break; Fracture; Difficult to Advance; Break; Fracture; Difficult to Advance

  A SHEPHERD .018 30G WIRE WAS USED IN AN ATTEMPT TO CROSS THE PROXIMAL END OF A COMPLETE TOTAL OCCLUSION (CTO) IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AFTER MULTIPLE ATTEMPTS TO CROSS THE CTO WITH THE WIRE, THE WIRE BROKE DURING RETRACTION, JUST PROXIMAL TO THE PROXIMAL 3CM TIP. THE FRACTURED SEGMENT BECAME STUCK IN A CALCIFIED BRANCH OR DISSECTION PLANE. THE FRACTURED SEGMENT WAS UNABLE TO BE REMOVED AND NO SNARE WAS AVAILABLE. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS DISCHARGED AFTER POST PROCEDURE ROUTINE CARE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923774 ↗
• MalfunctionAug 3, 2022Fracture; Failure to Advance; Fracture; Failure to Advance

  THE PHYSICIAN ADVANCED THE SHEPHERD GUIDE WIRE THROUGH THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH IN-STENT RESTENOSIS NEAR THE DISTAL SFA. THE GUIDE WIRE ADVANCED BEHIND THE STENT STRUT. THE GUIDE WIRE BEGAN TO BUCKLE WHEN THE PHYSICIAN BECAME AWARE IT WAS BEHIND THE STENT STRUT. THE GUIDE WIRE WAS ADVANCED PROXIMALLY WHEN THE TIP FRACTURED. THE TIP FRAGMENT WAS ENTRAPPED BY THE STENT AND REMAINS IN VIVO. SHEPHERD GUIDE WIRE TIP FRACTURED AND REMAINS ENTRAPPED IN VIVO BETWEEN THE STENT AND VESSEL.

  Patient problems: Vascular Dissection

  MAUDE report 15155349 ↗