Epic™ Vascular H74939200068020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805366), received between Feb 10, 2017 and Dec 2, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 2, 2025Contamination; Incomplete or Missing Packaging; Contamination; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE STENT WAS NOT IN A SEALED STERILE PACKAGE.THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER LEG. A 6X80X120 EPIC VASCULAR WAS SELECTED FOR RIGHT LOWER LEG ANGIOGRAPHY. HOWEVER, IT WAS NOTED THAT THE STENT WAS IN AN UNOPENED BOX BUT NOT IN A SEALED STERILE PACKAGE. THE DEVICE WAS IMMEDIATELY SET ASIDE AS SOON AS THE BOX WAS OPENED AND WAS NEVER INTRODUCED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695620 ↗
• MalfunctionJun 20, 2017Premature Activation; Device Damaged Prior to Use; Premature Activation; Device Damaged Prior to Use

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. A 6MMX80MMX120MM EPIC¿ STENT WAS SELECTED FOR USE. HOWEVER UPON OPENING THE PACKAGE, IT WAS NOTED THAT THE TIP OF THE STENT WAS PARTIALLY OUT OF THE DELIVERY SYSTEM. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A 6MMX80MM INNOVA STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 6654078 ↗
• InjuryFeb 10, 2017Bent; Bent

  SAME CASE AS MDR ID# 2134265-2017-00764. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN EPIC¿ VASCULAR STENT WAS ADVANCED AND IMPLANTED. THE DELIVERY SYSTEM AND GUIDEWIRE WERE INADVERTENTLY REMOVED TOGETHER FROM THE PATIENT. A NEW WIRE WAS ENGAGED AND POST-DILATION WAS PERFORMED. THE PHYSICIAN WAS NOT SATISFIED WITH THE RESULTS AND IMPLANTED A SECOND EPIC¿ VASCULAR DISTAL TO THE FIRST. UPON REMOVAL OF THE DELIVERY SYSTEM, THE NOSECONE BECAME STUCK ON THE PREVIOUSLY IMPLANTED STENT, CAUSING THE IMPLANTED STENT TO ELONGATE. THE DEVICE WAS REMOVED BY DISENGAGING THE WHEEL LOCK ON THE HANDLE AND RESHEATHING THE DEPLOYMENT SYSTEM. THE SECOND EPIC STENT WAS POST-DILATED. IT WAS NOTED THAT A VESSEL DISSECTION HAD OCCURRED. A NON-BSC STENT WAS DEPLOYED TO COVER BOTH PREVIOUSLY IMPLANTED STENTS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 6321670 ↗