Epic™ Vascular H74939200088070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729805731), received between Feb 10, 2020 and Jan 30, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Difficult to Insert; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT STRUTS PROTRUDED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. AN 8X80X75 EPIC STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING PREPARATION, THE STENT PROTRUDED SLIGHTLY ACCIDENTLY BY THE USER AND GOT CAUGHT ON THE Y-CONNECTOR, SO IT COULD NOT BE INSERTED INTO 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 24226626 ↗
• InjuryDec 16, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIALLY DEPLOYED, REQUIRING AN ADDITIONAL DEVICE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED EXTERNAL ILIAC ARTERY. AN 8X80X75 EPIC VASCULAR STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS INSERTED INTO THE BLOOD VESSELS AND CROSSED THROUGH THE LESION ONCE. AS THE STENT DEPLOYED DISTALLY UPON INITIATING DEPLOYMENT, IT WAS ATTEMPTED TO PULL THE SHAFT FOR REPOSITIONING, HOWEVER, THE SHAFT GOT STUCK. AS A RESULT, IT HAD TO BE PLACED AS IT WAS, MAKING IT UNABLE TO COVER THE LESION. SUBSEQUENTLY, AN ADDITIONAL STENT WAS USED WITH THE SAME PROCEDURE, AND IT HAD BEEN DEPLOYED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE VESSEL LESION WAS PRE-DILATED PRIOR TO STENT PLACEMENT. FURTHERMORE, THE SHAFT APPEARED TO BE STUCK WITHIN THE VESSEL. THE STENT WAS DEPLOYED APPROXIMATELY 1 CM BEFORE BEING PRESSED AGAINST THE VESSEL WALL. UPON INITIATING DEPLOYMENT OF THE STENT, THERE WAS NO RESISTANCE ENCOUNTERED WITH THE STENT DELIVERY SYSTEM, AND IT APPEARS TO HAVE BEEN WITHDRAWN WITHOUT ISSUE AFTER DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823812 ↗
• MalfunctionMar 29, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. AN 8X80X75 EPIC VASCULAR STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT ABOUT 1CM OF THE TIP OF THE STENT HAD BEEN DEPLOYED BEFORE PUTTING THE DEVICE IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635756 ↗
• MalfunctionNov 8, 2022Positioning Failure; Difficult to Advance; Positioning Failure; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT STENT DIFFICULTY ADVANCING AND DEPLOYMENT DIFFICULTY OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS ILIAC ARTERY. A 8X80X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING STENT DEPLOYMENT, THE THUMBWHEEL WAS ROTATED, BUT MARKER ON THE OUTER SHAFT WAS NOT MOVING UNDER FLUOROSCOPY, AND THE STENT COULD NOT BE DEPLOYED. THE ROTATION OF THE THUMBWHEEL FELT HEAVY, BUT IT DID NOT COME OFF OR BREAK DOWN. THE RESISTANCE WAS STRONGER THAN USUAL BECAUSE THE MEANDERING OF THE BLOOD VESSELS WAS STRONG, AND THE PLACEMENT OF THE STENT WAS DIFFICULT. THE USE OF THE DEVICE WAS STOPPED, AND IT WAS REMOVED FROM THE SHEATH AS IT WAS. THE PROCEDURE WAS COMPLETED WITH THE BALLOON ONLY AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753280 ↗
• MalfunctionFeb 10, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8X80X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WAS NOT TOTALLY DEPLOYED. THE DEVICE WAS COMPLETELY REMOVED FROM PATIENT'S BODY USING A 9FR CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687181 ↗