Epic™ Vascular H74939200108020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805083), received between Dec 18, 2018 and Jun 26, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED, REQUIRING INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 8X80X120 EPIC VASCULAR SELF-EXPANDING STENT WAS ADVANCE TO TREAT THE DISSECTION. HOWEVER, THE STENT DEPLOYED EARLY WHEN IT ARRIVED AT THE LESION SITE. THE SAFETY LOCK WAS REMOVED FROM THE HANDLE PRIOR TO POSITIONING THE DEVICE IN THE LESION. ANOTHER STENT WAS PLACED TO COMPLETE THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338998 ↗
• MalfunctionSep 16, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. DURING A PROCEDURE FOR PERCUTANEOUS TRANSHEPATIC BILIARY DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND SEED STENT IMPLANTATION, THIS 10X80X120 EPIC VASCULAR STENT SELF EXPANDING WAS CROSSED THE LESION SITE ALONG WITH V-18 GUIDEWIRE. DURING THE DEPLOYMENT PROCESS, THE STENT COULD NOT BE DEPLOYED IN THE SHEATH. AFTER IT WAS REMOVED, THE STENT DEPLOYED IN THE SHEATH. THE STENT AND SHEATH WERE WITHDRAWN TOGETHER FROM THE BODY AND CONFIRMED THAT THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231925 ↗
• MalfunctionDec 18, 2018Display or Visual Feedback Problem; Material Integrity Problem; Display or Visual Feedback Problem; Material Integrity Problem

  IT WAS REPORTED THAT MARKING BAND ISSUES OCCURRED. A 10X80X120MM EPIC STENT WAS SELECTED FOR A PERCUTANEOUS STENT IMPLANTATION. DURING THE PROCEDURE, THE PROXIMAL MARKER BAND OF THE DELIVERY SYSTEM COULD NOT BE VISUALIZED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175899 ↗