Epic™ Vascular H74939200104020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729805007), received between Dec 8, 2020 and Jul 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUBCLAVIAN ARTERY OF THE THORACIC AORTIC ANEURYSM. A 10X40X120 EPIC VASCULAR WAS SELECTED FOR USE. DURING ADVANCING, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION AND HAD A MARK OF KINK IN THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457203 ↗
• MalfunctionApr 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT UNDERWENT ENDOVASCULAR THERAPY (EVT) OF THE 90% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED COMMON ILIAC ARTERY (CIA) TO EXTERNAL ILIAC ARTERY (EIA). AN 8X100X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT USING AN APPROACH FROM THE UPPER EXTREMITIES. HOWEVER, A RESIDUAL STENOSIS WAS OBSERVED AT THE ORIGIN OF THE CIA WHICH WAS TREATED WITH AN 8.0X40X135 CM EXPRESS LD VASCULAR STENT AND COMPLETING THE PROCEDURE. FIFTEEN DAYS LATER, CLAUDICATION SYMPTOMS RECURRED, AND THE PATIENT VISITED THE CLINIC FOR AN OUTPATIENT CONSULTATION. THE EVT WAS THEREFORE RE-PERFORMED AS THROMBUS OCCLUSION WAS SUSPECTED BASED ON ECHOCARDIOGRAPHIC FINDINGS. ANGIOGRAPHY CONFIRMED THAT THE EXPRESS LD VASCULAR STENT HAD FLATTENED CAUSING VESSEL OCCLUSION AND OBSTRUCTED BLOOD FLOW. AFTER CROSSING THE GUIDEWIRE INTO THE FLATTENED STENT, A 10X40X120 EPIC VASCULAR STENT WAS IMPLANTED FROM THE INSIDE OF THE EXPRESS LD STENT TO CONFIRM EXPANSION. THE PROCEDURE WAS COMPLETED. 2 WEEKS LATER, FLUOROSCOPY REVEALED THAT THE EXPRESS LD AND 10X40X120 EPIC VASCULAR STENTS HAD ALSO FLATTENED IN THE SAME WAY. HOWEVER, NO RECURRENC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074179 ↗
• MalfunctionNov 20, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 10 X 40 X 120 EPIC STENT WAS PREPARED TO BE USED FOR TREATMENT. HOWEVER, UPON UNPACKING, IT WAS NOTED THAT THE STENT WAS KINKED AND THE TIP WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169684 ↗
• MalfunctionApr 11, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. AFTER UNPACKING OF A 10X40X120 EPIC VASCULAR STENT, THE TIP OF THE STENT WAS FOUND TO BE EXPOSED A LITTLE. THE DEVICE WAS TRIED TO BE WITHDRAWN BUT SOMEHOW THE DEVICE WAS MORE EXPOSED. THE STENT WAS NEVER USED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714773 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 10X40X120 EPIC VASCULAR STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, UPON REMOVING THE CATHETER, THE PHYSICIAN NOTED THAT THE INNER AND OUTER CATHETER HAD BECOME SEPARATED. THE DEVICE WAS REMOVED NORMALLY AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196217 ↗
• MalfunctionDec 8, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. A 10X40X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE RELEASE, THE THUMB WHEEL WAS VERY HARD AND VERY RISKY. IT WAS ALSO NOTED THAT THE SHAFT MAY HAVE BEEN STUCK AND WAS DIFFICULT TO PUSH AND WAS POSSIBLE TO PULL. EVENTUALLY, THE DEVICE WAS ABLE TO REMOVE WITHOUT ANY PROBLEMS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971075 ↗