Epic™ Vascular H74939200094070Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729805793), received between Jun 15, 2021 and Mar 3, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Positioning Problem

  IT WAS REPORTED THAT STENT JUMPING OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 9X40X75 EPIC STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, STENT JUMPING OCCURRED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497230 ↗
• MalfunctionOct 5, 2022Difficult to Insert; Premature Activation; Difficult to Insert; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS VESSEL IN THE LEFT FOREARM. A 9X40X75 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE PHYSICIAN ATTEMPTED TO LOAD THE STENT ONTO THE GUIDEWIRE BUT COULD NOT ADVANCE IT INTO THE SHEATH BECAUSE THE STENT STARTED TO DEPLOY. THEY TRIED TO SEE IF THE STENT WOULD GET COVERED BY DELIVERY SYSTEM BUT COULD NOT. THE PROCEDURE WAS COMPLETED WITH AN INNOVA SELF-EXPANDING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547050 ↗
• MalfunctionNov 15, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT INCORRECT STENT PLACEMENT OCCURRED. THE 9X40X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THE STENT WAS NOT PLACED IN THE CORRECT LOCATION. IT WAS NOT REPORTED OF THE STENT WAS FULLY EXPANDED. THE STENT DELIVERY SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814439 ↗
• MalfunctionNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 9X40X75 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE DEVICE BROKE OFF BEFORE LOADING ONTO THE WIRE. THE STENT WAS NEVER INSERTED INTO PATIENT. THE PROCEDURE WAS COMPLETED WIT ANOTHER EPIC STENT OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804902 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE RIGHT EXTERNAL ILIAC. A 9MM X 40MM EPIC STENT, A 7MM X 60MM ELUVIA STENT AND 7MM X 40MM MUSTANG WERE SELECTED FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE IN THE EXTERNAL ILIAC. THE LESION WAS PRE-DILATED WITH A 5MM X 100MM MUSTANG BALLOON FOLLOWED BY AN ARTERIOGRAM TO MARK THE LANDING ZONES. A 9MM X 40MM EPIC STENT AND A 7MM X 60MM ELUVIA STENT WERE PLACED TO TREAT THE LESION. POST DILATION WAS PERFORMED WITH A 7MM X 40MM MUSTANG. THE CERTIFIED RN ANESTHETIST NOTICED CHANGES IN THE PATIENT'S CARBON DIOXIDE LEVELS AND BLOOD PRESSURE. REPEAT ARTERIOGRAMS WERE PERFORMED REVELING A PERFORATION IN THE RIGHT EXTERNAL ILIAC. HYPOTENSION AND BLOOD LOSS WERE REPORTED AS A RESULT OF THE PERFORATION. IT WAS THOUGHT THAT THE PERFORATION POSSIBLY OCCURRED DURING POST DILATION OF THE STENTS AND CALCIFICATION OF THE LESION CONTRIBUTED TO THE PERFORATION. THE PERFORATION WAS TREATED USING A NON-BOSTON SCIENTIFIC STENT AND MULTIPLE LONG BALLOON INFLATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AFTER THE PERFORATION WAS TREATED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 12802589 ↗
• MalfunctionJul 5, 2021Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9X40X75 EPIC VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, RESISTANCE WAS FELT WHILE TRYING TO DEPLOY THE STENT. UPON REMOVING THE CATHETER, THE STENT DEPLOYED IN THE SHEATH. THE SHEATH AND THE STENT WERE REMOVED, AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119369 ↗
• InjuryJun 15, 2021Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. FOLLOWING PRE-DILATATION WITH A MUSTANG BALLOON CATHETER, A 9X40X75 EPIC STENT SELF EXPANDING WAS IMPLANTED. HOWEVER, THE STENT MIGRATED TO THE MIDDLE PART OF THE ILIAC VEIN. ANOTHER EPIC STENT SELF EXPANDING WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12000096 ↗