Epic™ Vascular H74939200086070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729805694), received between Feb 2, 2021 and Nov 26, 2025 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED PORTAL VEIN. AN 8X60X75 EPIC VASCULAR STENT SELF-EXPANDING WAS SELECTED FOR USE. UPON INSERTION OF THE STENT INTO THE LESION THROUGH THE 7FR SHEATH, THE OUTER SHAFT RETRACTED BEFORE REACHING THE TARGET LESION, CAUSING THE STENT TO BEGIN TO DEPLOY. THE USE OF THE STENT WAS DISCONTINUED BEFORE IT COULD BE PRESSED AGAINST THE VESSEL. 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 23660670 ↗
• MalfunctionMar 18, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. AN 8X60X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE VIA CONTRALATERAL APPROACH. HOWEVER, AFTER DEPLOYMENT, THE DELIVERY SYSTEM COULD NOT BE DISENGAGED FROM THE GUIDEWIRE. THE GUIDEWIRE COULD NOT BE SEPARATED FROM THE DELIVERY SYSTEM EVEN OUTSIDE THE PATIENT. A NEW GUIDEWIRE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923758 ↗
• 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 18740570 ↗
• DeathFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION AND BLEEDING OCCURRED, AND THE PATIENT DIED. THE 100% STENOSED, 8MM X 15 CM IN LENGTH TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT ILIAC ARTERY. AN 8X60X75 AND 10X80X75 EPIC VASCULAR STENTS WERE ADVANCED AND IMPLANTED WITHOUT ISSUE. POST DILATATION WAS THEN PERFORMED WITH AN 8.0MMX60MMX135CM STERLING BALLOON CATHETER; HOWEVER, PERFORATION WAS NOTED. THE PHYSICIAN ADMINISTERED PROTAMINE TO THE PATIENT. HEMOSTASIS WAS THEN PERFORMED BY DILATATION FOR 80 MINUTES WITH THE SAME BALLOON CATHETER AND THE DEVICE WAS ABLE TO STOP THE BLEEDING. ON THE FOLLOWING DAY, RE-BLEEDING WAS NOTED, AND 2 NON-BOSTON SCIENTIFIC STENTS WERE PLACED. TWO DAYS POST PROCEDURE, THE PATIENT DIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 11267454 ↗