Epic™ Vascular H74939200101070Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729805113), received between Feb 28, 2017 and Mar 10, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 16, 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 10, 2026Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 90% TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL OF THE ILIAC. A 10X100X75 EPIC VASCULAR SELF-EXPANDING WAS SELECTED FOR USE. DURING ADVANCING ALONG WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE, IT BECAME STUCK. UPON REMOVAL, THE GUIDEWIRE COULD NOT BE REMOVED, SO THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDEWIRE. 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 24561039 ↗
• MalfunctionMay 2, 2024Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-APR-2023. IT WAS REPORTED THAT DEVICE DIFFICULT TO CROSS OCCURRED. THE 70-80 CALCIFIED LESION WAS LOCATED IN THE ILIAC ARTERY. A 10X100X75 EPIC VASCULAR STENT SELF EXPANDING WAS ADVANCED FOR TREATMENT DURING THE PROCEDURE, THE DEVICE COULD NOT PASS THE ANGLE OF THE LESION DUE TO THE RESISTANCE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED DURING WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228473 ↗
• MalfunctionJun 6, 2023Break; Positioning Failure; Difficult to Advance; Break; Positioning Failure; Difficult to Advance

  IT WAS REPORTED, THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE IPSILATERAL SIDE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS, AND MODERATELY CALCIFIED ILIAC ARTERY. AFTER A 0.014-INCH GUIDEWIRE WAS CROSSED, A 10X100X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. MEANDERING WAS VERY STRONG, AND RESISTANCE WAS FELT IN ADVANCING THE STENT INTO THE LESION. AN ATTEMPT WAS MADE TO DEPLOY THE STENT, BUT FAILED EVEN AFTER TURNING THE WHEEL AT ABOUT 20 TICKS. THE DEVICE WAS REMOVED, BUT IT WAS OBSERVED, THAT THE OUTER SHAFT CAME OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073958 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE OUTER SHEATH DETACHED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERLY TORTUOUS AND SEVERLY CALCIFIED LEFT COMMON ILIAC ARTERY. A 10MM X 100MM X 75MM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT USING AN IPSILATERAL ANTEGRADE APPROACH. AFTER THE GUIDEWIRE WAS PASSED THROUGH, THE EPIC STENT WAS DELIVERED AFTER PRE-DILATATION WAS PERFORMED, HOWEVER, IT FAILED TO DEPLOY. WHEN TRYING TO REMOVE THE DEVICE, THE OUTER SHEATH BECAME SEPARATED/DETACHED. THE PROCEDURE COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS REPORTED AS STABLE. IT WAS FURTHER REPORTED THAT THE OUTER SHEATH WAS ACCORDIONED AND NOT SEPARATED/DETACHED. THE DAMAGE WAS LOCATED WITHIN 10CM FROM THE HUB, BUT THE EXACT LOCATION WAS UNKNOWN. THE PATIENT'S CURRENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8444398 ↗
• MalfunctionDec 14, 2018Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-DEC-2018. IT WAS REPORTED THAT STENT FAILURE TO DEPLOY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 10X100X75MM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. THE THUMBWHEEL WAS ROTATED BY THE PRESCRIBED METHOD IN ORDER TO DEPLOY, BUT THE OUTER SHEATH COULD NOT BE PULLED AND THE DEVICE WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED OUTER SHEATH DETACHMENT FROM PULL GRIP AND STENT PARTIAL DEPLOYMENT. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN EPIC SELF-EXPANDING STENT SYSTEM. THE OUTER SHEATH, TIP, INNER SHEATH AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION REVEALED THAT THE OUTER SHEATH IS DETACHED FROM THE PULL GRIP. THE RACK IS FULLY INSIDE THE HANDLE SO IT IS NO LONGER VISIBLE. MICROSCOPIC EXAMINATION REVEALED THAT THE STENT IS PARTIALLY DEPLOYED APPROXIMATELY 1MM FROM THE MIDDLE SHEATH. THERE IS BLOOD PRESENT IN THE MIDDLE SHEATH AND ON THE STENT. INSPECTION OF THE REMAINDER O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165145 ↗
• MalfunctionOct 27, 2017Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT THE STENT WOULD NOT DEPLOY. A 10X100X75 EPIC VASCULAR STENT WAS SELECTED FOR A BILIARY STENTING PROCEDURE AND IT WAS REPORTED THAT THE STENT WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD. HOWEVER RETURNED ANALYSIS REVEALED A PARTIALLY DEPLOYED STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6984592 ↗
• MalfunctionFeb 28, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT WIRE ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A NON BSC GUIDEWIRE WAS BEING ADVANCED THROUGH A 10X100X75 EPIC¿ STENT DELIVERY SYSTEM WHEN THE GUIDEWIRE BECAME STUCK MIDWAY. THE NON BSC GUIDEWIRE AND EPIC¿ STENT DELIVERY SYSTEM WERE REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6364555 ↗