Epic™ Vascular H74939200126020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729805182), received between Aug 15, 2019 and Nov 24, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2025. IT WAS REPORTED THAT SHAFT KINKED OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 12X60X120 EPIC STENT SELF EXPANDING WAS SELECTED FOR ANGIOPLASTY OF ILIAC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE TIP OF THE DELIVERY DEVICE WAS KINKED, AND THE GUIDE WIRE COULD NOT CROSS THE DELIVERY DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIALLY DEPLOYED STENT. IT WAS FURTHER REPORTED THAT THE STENT WAS DEPLOYED INADVERTENTLY DURING TRANSIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633656 ↗
• InjuryAug 15, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA IPSILATERAL APPROACH. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED PORTAL VEIN. A 12 X 60 X 120 MM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING STENT DEPLOYMENT, RESISTANCE WAS ENCOUNTERED BUT EVENTUALLY, THE STENT WAS DEPLOYED. POST DEPLOYMENT, THE MEASUREMENT OF THE STENT WAS OBSERVED TO BE 30 MM UNDER RADIOGRAPHY WHICH COULD NOT FULLY COVER THE LESION. SUBSEQUENTLY, THE PHYSICIAN IMPLANTED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898676 ↗