Shepherd PSP14S-30004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10850026568544), received between Sep 20, 2022 and Jul 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED TWO SHEPHERD .014" GUIDEWIRE - STRAIGHT - 30G AND BOTH BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22455811 ↗
• MalfunctionMar 31, 2025Material Integrity Problem; Device Handling Problem; Material Integrity Problem; Device Handling Problem

  A WIRE EXCHANGED WAS PERFORMED FOR A SHEPHERD GUIDE WIRE TO TREAT A MODERATELY CALCIFIED, NON-TORTUOUS, 50% STENOSED LESION IN POSTERIOR TIBIAL ARTERY (PT) THROUGH COMMON FEMORAL ARTERY (CFA). DURING TREATMENT, THE WIRE BECAME STUCK. THE WIRE WAS PULLED TO LOOSEN IT FROM THE VESSEL. FLUOROSCOPY IMAGING WAS PERFORMED AND REVEALED THE TIP OF THE WIRE HAD FRACTURED. THE FRACTURED COMPONENT WAS TOO SMALL TO BE SNARED AND WAS LEFT IN VIVO. THERE WAS NO INDICATION WHY THE WIRE FRACTURED. THE PATIENT WAS STABLE WITH NO COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21729454 ↗
• MalfunctionMar 11, 2024Break; Break

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS POSITIONED ON THE WIRE AND TESTED BEFORE ENTERING THE BODY. THE CROWN OF THE OAD WAS CAUGHT ON A BLUE STERILE TOWEL. A REPLACEMENT OAD WAS USED TO COMPLETE THE PROCEDURE. A SHEPHERD PERIPHERAL GUIDE WIRE TIP BROKE OFF DURING THE SAME PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18875128 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  A SHEPHERD GUIDE WIRE WAS BEING USED TO ACCESS THE ANTERIOR TIBIAL ARTERY THROUGH A PEDAL RETROGRADE APPROACH TO ADVANCE PAST A CHRONIC TOTAL OCCLUSION (CTO) WHEN THE TIP OF THE SHEPHERD WIRE WAS DISLODGED AND FRACTURED IN THE CTO. THE FRACTURED TIP WAS STUCK IN THE ADVENTITIA LAYER OF THE ARTERY. AN ADDITIONAL SURGERY WAS PERFORMED TO SNARE THE BROKEN TIP OF THE WIRE. THE PATIENT WAS IN STABLE CONDITION AND HAD GOOD FLOW OF THE TREATED VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 16022124 ↗
• MalfunctionSep 20, 2022Flaked; Peeled/Delaminated; Mechanical Jam; Flaked; Peeled/Delaminated; Mechanical Jam

  THE PHYSICIAN INTRODUCED A SHEPHERD GUIDE WIRE AND JADE BALLOON TO ANGIOPLASTY A SEGMENT OF THE ANTERIOR TIBIAL ARTERY (AT). AFTER DEFLATION, THE PHYSICIAN ATTEMPTED TO WALK THE BALLOON DISTALLY TO TREAT THE NEXT DISEASED SEGMENT BUT RESISTANCE WAS EXPERIENCED AND THE BALLOON WOULD NOT CROSS. THE PHYSICIAN ATTEMPTED TO PUSH AND PULL THE GUIDE WIRE, HOWEVER, RESISTANCE WAS FELT WHEN THE GUIDE WIRE WAS PULLED BACK. UNDER FLUOROSCOPY, THE PHYSICIAN REMOVED THE GUIDE WIRE AND BALLOON TOGETHER. THE POLYMER COATING OF THE GUIDE WIRE WAS OBSERVED TO BE STRIPPED AND BUNCHED, WHICH PREVENTED THE BALLOON TO BE PUSHED DISTALLY. THE PHYSICIAN USED A NON-CSI GUIDE WIRE TO DELIVER THE BALLOON CATHETER DISTALLY AND FINISH THE ANGIOPLASTY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15455206 ↗