Epic™ Vascular H74939200098020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805861), received between Feb 10, 2021 and Feb 6, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryFeb 6, 2024Material Separation; Material Separation

  IT WAS REPORTED VIA USER MEDWATCH MW5149467 THAT MATERIAL SEPARATION AND UNRETRIEVABLE DEVICE COMPONENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT EXTERNAL ILIAC ARTERY. A 9X80X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE NOSE CONE DETACHED FROM THE STENT. THE DETACHED COMPONENT COULD NOT BE RETRIEVED AS IT WAS NOT RADIOPAQUE AND COULD NOT BE SEEN WHERE IT WAS LODGED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18653009 ↗
• InjuryNov 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ARTERY. A 9 X 80 X 120 EPIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON REMOVE, IT WAS NOTED THAT THE TIP WAS MISSING FROM THE NOSE CONE FROM THE DELIVERY SYSTEM. MULTIPLE ANGIOGRAMS WERE DONE ON THE VESSELS. THE TIP WAS NOT RADIOPAQUE AND THERE WERE NO EMBOLISMS CAUSED FROM THE TIP. THE DETACHED PORTION REMAINS INSIDE THE PATIENT AND THEY ARE ARRANGED FOR A FOLLOW UP TO CHECK THE ANKLE BRACHIAL INDEX AND AN ULTRASONOGRAM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18208690 ↗
• InjuryFeb 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. A 9X80X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT SEEMED TO FORESHORTEN BY AT LEAST 20 MM. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT REMOVED AND THE PROCEDURE WAS COMPLETED BY USING ADDITIONAL STENT TO COVER THE STENOSED AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306768 ↗