Epic™ Vascular H74939200066020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729805328), received between Feb 10, 2017 and May 12, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 12, 2020Premature Activation; Activation, Positioning or Separation Problem; Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT INADVERTENT AND PARTIAL STENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OF THE RIGHT LOWER EXTREMITY. A 6X60X120 EPIC STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS TAKEN OUT FROM THE PROTECTIVE SLEEVE, IT WAS NOTED THAT THE FIRST AND SECOND SECTIONS OF THE STENT WERE DEPLOYED AND COULD NOT BE RECONSTRAINED BACK INTO THE DELIVERY SYSTEM. THE DEVICE WAS COMPLETELY REMOVED WITHOUT ANY ISSUE. 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 10048486 ↗
• MalfunctionMar 24, 2020Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION AND BALLOON RUPTURE OCCURRED. A 6X60X120 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT WAS CONTAMINATED BY TECHNOLOGIST. ANOTHER EPIC STENT OF AN UNKNOWN SIZE WAS SUCCESSFULLY USED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AFTER AN UNKNOWN EPIC STENT WAS DEPLOYED, A 8.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9873794 ↗
• MalfunctionOct 4, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. A 6X60X120 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT CAME OFF THE STENT DELIVERY SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9156109 ↗
• MalfunctionApr 19, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A HYPOTUBE DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE 6X60X120 EPIC¿ VASCULAR STENT WAS DEPLOYED OVER AN UNSPECIFIED .035 WIRE. THE STENT DEPLOYED FINE. UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTICED THAT THE INNER HYPOTUBE HAD COME DISLODGED OFF OF THE DELIVERY SYSTEM. EVERYTHING WAS REMOVED OUT FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6503618 ↗
• InjuryFeb 10, 2017Difficult to Remove; Difficult to Remove

  SAME CASE AS MDR ID# 2134265-2017-00843. 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 6321659 ↗