Epic™ Vascular H74939200084020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729805649), received between Feb 6, 2020 and Nov 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN UNSPECIFIED STENT WAS SELECTED FOR USE DURING THE PROCEDURE. HOWEVER, IT WAS NOTED THAT THE DISTAL TIP OF THE DEVICE WAS DAMAGED. THE STENT WAS THEN REPLACED WITH AN 8X40X120 EPIC VASCULAR STENT; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION. CONSEQUENTLY, THE PROCEDURE COULD NOT BE COMPLETED. NO PATIENT INJURY WAS REPORTED. IT WAS FURTHER REPORTED THAT TWO 8X40X120 EPIC VASCULAR STENTS WERE USED IN THE PROCEDURE, MOREOVER, THE PATIENT WAS LOCALLY SEDATED WHEN THE ISSUE OCCURRED, AND THE DEVICE WAS REMOVED USING THE NORMAL METHOD DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708471 ↗
• MalfunctionDec 2, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. DURING UNPACKING OF AN 8X40X120 EPIC VASCULAR STENT AND WHEN IT WAS ABOUT TO ADVANCE THROUGH THE GUIDEWIRE, THE TIP OF THE STENT WAS FOUND TO BE PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906488 ↗
• MalfunctionAug 30, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT ILIAC ARTERY. AN 8X40X120 EPIC VASCULAR STENT WAS SELECTED FOR USE; HOWEVER, WHEN THE PHYSICIAN OPENED THE PACKAGE, HE FOUND THE STENT WAS OUTSIDE THE PROTECTIVE DELIVERY SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320873 ↗
• MalfunctionMay 24, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN ILIAC ARTERY. A 8X40X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, WHEN THE STENT WAS FLUSHED, THE TIP OF THE STENT AUTOMATICALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492828 ↗
• MalfunctionFeb 6, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PARTIAL INADVERTENT DEPLOYMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. DURING UNPACKING OF A 8X40X120 EPIC STENT, IT WAS NOTED THAT THE TAIL END OF THE STENT HAD DEPLOYED 0.5CM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9676747 ↗