Epic™ Vascular H74939200076020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805489), received between Sep 6, 2018 and Jun 10, 2021 — classified as 3 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.

• MalfunctionJun 10, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT DETACHMENT OCCURRED. A 7X60X120 EPIC VASCULAR STENT WAS SELECTED FOR USED. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS DETACHED FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977607 ↗
• MalfunctionOct 23, 2020Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE LEFT FEMORAL ARTERY. AFTER A 7F NON-BOSTON SCIENTIFIC SHEATH AND A 0.035 AMPLATZ GUIDE WIRE CROSSED THE LESION, A 7X60X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT REACHED THE LESION, THE HANDLE ROLLER COULD NOT BE ROTATED AND THE STENT COULD NOT BE DEPLOYED EVEN AFTER REPEATED ATTEMPTS. WHEN THE DEVICE WAS REMOVED, THE MIDDLE OF THE STENT STRUTS WERE FOUND TO BE DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726416 ↗
• MalfunctionSep 6, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIALLY DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LOWER EXTREMITY. A 7X60X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT FLOWERED OUT BUT IT COULD GET TO FINISH DEPLOYING. THE WHOLE SYSTEM WAS TAKEN OUT FORM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852088 ↗