Epic™ Vascular H74939200106070Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729805052), received between Feb 6, 2017 and Dec 16, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Break; Entrapment of Device; Difficult to Advance; Break; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. VASCULAR ACCESS WAS VIA A RIGHT COMMON FEMORAL ARTERY (CFA) CONTRALATERAL APPROACH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 10X60X75 EPIC SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, ANGLE OF THE ABDOMINAL AORTIC BIFURCATION WAS STEEP, THE GUIDING SHEATH WAS ACHIEVED UP TO PRE-DILATION, THOUGH NAVIGATION WAS CHALLENGING. WHEN INTRODUCING THE DEVICE, RESISTANCE AND STIFFNESS WERE NOTED, PROMPTING CAREFUL MANIPULATION; HOWEVER, IT COULD NOT REACH THE LESION. ATTEMPTS TO RETRIEVE THE DEVICE FAILED, REQUIRING REMOVAL OF BOTH THE DEVICE AND GUIDEWIRE TOGETHER. EXAMINATION REVEALED A FRACTURED PROXIMAL SHAFT, RENDERING THE DEVICE UNUSABLE. THERE WAS NO PROCEDURAL FACTORS CONTRIBUTE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822331 ↗
• MalfunctionMar 5, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. A 10X60X75 EPIC VASCULAR STENT BALLOON WAS SELECTED FOR USE IN AN ILIAC ANGIOPLASTY. THE DEVICE WAS FLUSHED AND LOADED ONTO THE WIRE; HOWEVER, IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT WAS EXPOSED AND PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A NEW 10X40 EPIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840299 ↗
• MalfunctionAug 7, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. AFTER SUCCESSFUL DEPLOYMENT OF A 10X60X75MM EPIC STENT, THE STENT DELIVERY SYSTEM WAS STUCK WITH THE .035 NON-BSC GUIDEWIRE AND WERE REMOVED TOGETHER. A NEW WIRE WAS USED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382066 ↗
• InjuryApr 15, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT PARTIALLY EXPANDED OCCURRED. A 10X60X75MM EPIC VASCULAR STENT WAS INSERTED AND DEPLOYED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE STENT DID NOT FULLY EXPAND AT DISTAL END. THE DEVICE HAS ENDED UP BEING PINCHED ON THE END EVEN AFTER IT WAS BALLOONED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9962495 ↗
• MalfunctionFeb 25, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 10X60X75MM EPIC STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, DURING POST-DILATION WITH A 8X60MM STERLING BALLOON CATHETER, IT WAS NOTED THAT THE STENT WAS 1-2CM LONGER THAN THE 60MM BALLOON. THE PHYSICIAN SUSPECTS THE STENT LENGTH ELONGATED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752305 ↗
• InjuryFeb 14, 2019Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN A FISTULA. A NON-BSC BALLOON WAS ATTEMPTED TO BE ADVANCED AND WAS UNSUCCESSFUL. A 10X60X75 EPIC VASCULAR STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT MIGRATED FORWARD AND MISSED THE LESION. THE PHYSICIAN OPENED ANOTHER 9X60X75 EPIC VASCULAR STENT AND THE SAME THING HAPPENED. THE STENTS MIGRATED IN THE FISTULA AND WERE LEFT INSIDE THE PATIENT'S BODY AS RETRIEVING THE STENTS WOULD CAUSE MORE DAMAGE TO THE FISTULA. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SUBOPTIMAL RESULT. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341002 ↗
• MalfunctionFeb 6, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT ISSUE OCCURRED. DURING PREPARATION OF A 10X60X75 EPIC¿ VASCULAR STENT, UPON REMOVAL OF THE DEVICE FROM ITS CASE, IT WAS NOTED THAT THE STENT MARKER PART PROTRUDED FROM THE DISTAL TIP. THE YELLOW LOCK OF THE GRIP WAS CONNECTED AND NO DIAL OPERATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6304176 ↗