Epic™ Vascular H74939200084070Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729805656), received between Apr 30, 2018 and May 7, 2026 — classified as 1 injury, 9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MARKERBAND ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC ARTERY. A 10MM X 40MM X75 EPIC? VASCULAR SELF-EXPANDING STENT WAS PLACED IN THE PROXIMAL ILIAC, FOLLOWED BY A 10MM X 50MM NON-BOSTON SCIENTIFIC STENT PLACED DISTAL TO THE FIRST STENT, AND FINALLY AN 8X40X75 EPIC? VASCULAR SELF-EXPANDING STENT WAS PLACED DISTAL TO THE NON-BSC STENT. AFTER STENTING, ANGIOGRAPHY CONFIRMED PATENT FLOW THROUGH THE ILIAC ARTERY WITH NO CONCERNS. HOWEVER, A POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT ONE OF THE FIVE RADIOPAQUE (RO) MARKER BANDS AT THE DISTAL END OF AN EPIC STENT APPEARED IN THE CENTER OF THE VESSEL. THIS WAS NOTED TO BE ABNORMAL BASED ON IMAGING THAT THE RO BAND WOULD NOT BE OPPOSED TO THE VESSEL WALL. THERE WERE NO PLANS TO REMOVE THE STENTS, AND THE PATIENT WAS SCHEDULED FOR DUPLEX ULTRASOUND IN TWO WEEKS TO CONFIRM CONTINUED BLOOD FLOW. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117923 ↗
• MalfunctionOct 31, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. AN 8 X 40 X 75 EPIC STENT SELF-EXPANDING WAS SELECTED FOR ENDOVASCULAR TREATMENT TO TREAT LOWER EXTREMITY ARTERY DISEASE. DURING THE PROCEDURE, A CONTRALATERAL APPROACH WAS USED. AFTER PLACEMENT WITH A NON-BOSTON SCIENTIFIC INTRODUCER SHEATH FROM THE LEFT FEMORAL ARTERY, THE STENT WAS ADVANCED DIRECTLY TO THE LESION PART. HOWEVER, THE TIP OF THE STENT GOT STUCK DURING ADVANCEMENT, WHICH RESULTED IN A KINK FROM THE MID-SHAFT TOWARDS THE SIDE OF THE TIP. THE PHYSICIAN COULD NOT FULLY DETERMINE WHERE IT GOT STUCK AND KINKED AS THE STENT ADVANCED QUICKLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437822 ↗
• MalfunctionJul 29, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. AN 8X40X75 EPIC VASCULAR STENT WAS SELECTED FOR AN ENDOVASCULAR THERAPY. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS SLIGHTLY PROTRUDING WHEN IT WAS TAKEN OUT. IT WAS NOTED THIS OCCURRED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, MILDLY TORTUOUS AND MILDLY CALCIFIED, AND WAS LOCATED IN THE ILIAC ARTERY. FURTHERMORE, THERE WAS NO DAMAGE NOTED ON THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856960 ↗
• MalfunctionFeb 20, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT DIFFICULTY TO POSITION OCCURRED. PATIENT UNDERWENT A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED GRAFT AND ANASTOMOSIS. STENT IMPLANTATION WAS NOT INDICATED BUT STILL PERFORMED AFTER A 6X100X75 MUSTANG BALLOON CATHETER WAS PERFORMED FOR PRE-DILATION. AN 8X40X75 EPIC STENT WAS INITIALLY IMPLANTED. AFTER DEPLOYMENT, IT APPEARED TO BE SKIPPING AS IF IT WAS BEING PUSHED. THE PHYSICIAN HAD USED THIS DEVICE BEFORE. AN 8X60X75 EPIC STENT WAS ATTEMPTED TO BE IMPLANTED TO COVER THE LESION, BUT THE SAME EVENT OCCURRED WHERE IT SEEMED TO BE SKIPPING. PER METHOD OF USE, THE STENT MUST BE SET ASIDE WHEN POSITIONING TO AVOID RESISTANCE ON THE SHAFT. THIS WAS ATTEMPTED, HOWEVER, THERE WAS SKIPPING AFTER DEPLOYMENT DESPITE AN OVERLAP OF MORE THAN 2CM ON THE GRAFT. APPROXIMATE 4CM APPEARED TO BE SKIPPING AND IT CAME OUT AHEAD OF THE FIRST 4CM OF THE EPIC. THE LESION WAS NOT COVERED, AND THE PROCEDURE WAS DISCONTINUED. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740561 ↗
• MalfunctionFeb 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AN 8X40X75 EPIC VASCULAR STENT WAS ADVANCED TO TREAT THE TARGET LESION IN THE ILIAC ARTERY. THE STENT WAS WITHDRAWN AND OPENED OUTSIDE THE PATIENT; HOWEVER, IT WAS NOTED THAT THE TIP WAS ALREADY DAMAGED AND HAD NO HOLES FOR WIRES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303599 ↗
• InjuryAug 23, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT POSITIONING DIFFICULTIES WERE ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AFTER PLACEMENT OF A 8-100 EPIC STENT IN THE LESION, A 8X40X75 EPIC VASCULAR STENT WAS ADVANCED TO OVERLAP A RESIDUAL STENOSIS OF THE STENT PERIPHERAL. HOWEVER, DURING DEPLOYMENT, THE STENT WAS PUSHED INTO THE DISTAL WHICH PREVENTED IT FROM COVERING THE LESION. ANOTHER 8-60 EPIC STENT WAS PLACED IN A FURTHER OVERLAPPING FORM AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277525 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED FISTULA OF THE LEFT ARM. A 8X40X75 EPIC VASCULAR STENT WAS ADVANCED AND DEPLOYED TO TREAT THE LESION. HOWEVER, DURING REMOVAL, IT WAS NOTICED THAT THE INNER WHITE SHAFT WAS SEPARATED AND WAS MOVING FREELY FROM THE HANDLE. THE SHAFT DID NOT DISLODGE ENTIRELY FROM THE STENT DELIVERY SYSTEM. THE DEVICE WAS REMOVED WITH EASE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559614 ↗
• MalfunctionApr 22, 2020Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN 8X40X75 EPIC VASCULAR STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS STUCK AND WHEN IT WAS REMOVED, IT WAS KINKED DUE TO PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985884 ↗
• MalfunctionJun 12, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. AFTER A GUIDE WIRE CROSSED THE LESION AND PRE-DILATATION WAS PERFORMED, AN 8X40X75 EPIC¿ VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DISTAL TIP GOT CAUGHT IN THE CALCIFICATION AND IT FAILED TO CROSS THE LESION. THE DEVICE WAS COMPLETELY REMOVED AND IT WAS NOTED THAT THE DISTAL TIP OF THE STENT STRUTS WERE SLIGHTLY LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7592738 ↗
• MalfunctionApr 30, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ILIAC ARTERY TO THE AORTA. AFTER A GUIDE WIRE WAS ADVANCED, A 8X40X75MM EPIC¿ VASCULAR STENT WAS SELECTED FOR USE TO TREAT THE LESION AND IN THE PART THAT WAS NOT SUFFICIENTLY DILATED. HOWEVER, THE DEVICE WAS UNABLE TO ADVANCE OUTSIDE THE BODY MIDWAY OF THE GUIDE WIRE AND IT GOT STUCK. WHEN THE DEVICE WAS PUSHED STRONGLY, THE STENT WAS DEPLOYED AT ABOUT 2 CM FROM THE TIP OF THE SHAFT. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDE WIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 9X40MM EPIC¿ VASCULAR STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473633 ↗