Epic™ Vascular H74939200124070Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729805151), received between Dec 2, 2016 and Jan 22, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ABDOMINAL AORTA. A 12X40X75 EPIC WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE STENT WAS PREPARED AND ATTEMPTED TO BE ADVANCED ALONG THE GUIDEWIRE, IT WAS NOTED THAT THE TIP APPEARED TO BE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152090 ↗
• MalfunctionDec 22, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 12X40X75 EPIC VASCULAR SELF-EXPANDING WAS SELECTED FOR USE. DURING DEVICE PREPARATION, IT WAS NOTED THAT THE PLASTIC SEAL OF THE DEVICE WAS TORN. THERE WAS NO DAMAGE TO THE OUTER BOX. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE OUTER PACKAGING OF THE PRODUCT WAS TORN, AND SINCE THIS WAS OBSERVED BEFORE OPENING THE BOX, THE STERILITY OF THE INNER POUCH OR DEVICE COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864264 ↗
• InjuryOct 19, 2023Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT STENT MIGRATION AND FRACTURE OCCURRED. A 12X40X75 EPIC VASCULAR STENT MIGRATED AND UPON RETRIEVING THE MIGRATED STENT, IT FRAGMENTED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967985 ↗
• MalfunctionJul 11, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ILIAC ARTERY. A 12X40X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE STUCK WITH A 0.035IN NON-BOSTON SCIENTIFIC GUIDEWIRE. THE STENT AND THE GUIDEWIRE WERE REMOVED TOGETHER, AND 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 17299050 ↗
• MalfunctionApr 12, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER BECAME STUCK ON THE GUIDEWIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ILIAC ARTERY. AFTER THE LESION WAS CROSSED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE AND PRE-DILATED WITH A BALLOON CATHETER, TWO DIFFERENT SIZE EPIC STENTS WERE PLACED IN ADVANCE. A 12X40X75MM EPIC VASCULAR STENT WAS THEN USED FOR TREATMENT, BUT BECAUSE THE DEVICE WAS NOT SMOOTH ENOUGH FROM THE TIME IT WAS INSERTED FROM THE SHEATH ALONG THE GUIDEWIRE, THE GUIDEWIRE WAS MOISTENED WITH HEPARINIZED SALINE SOLUTION. SINCE THE SYSTEM WAS ABLE TO ADVANCE TO THE TARGET LESION, THE STENT WAS PLACED. THE STENT DELIVERY SYSTEM WAS TRIED TO BE REMOVE LEAVING THE GUIDEWIRE AND THEN CONTINUE POST-DILATION AND INTRAVASCULAR ULTRASOUND; HOWEVER, IT GOT STUCK WITH THE GUIDEWIRE AND HAD TO REMOVE THE ENTIRE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649806 ↗
• MalfunctionApr 17, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. A 12X40X75MM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE ANGLE OF THE BLOOD VESSEL AT THE PART THAT ENTERED THE SUPERIOR VENA CAVA FROM THE SUBCLAVIAN WAS STEEP UPON APPROACH TO THE LEFT BRACHIAL VEIN AND IT WAS DIFFICULT TO DEPLOY. IT WAS NOTICED THAT THE DISTAL END OF THE STENT WAS SLIGHTLY DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9972260 ↗
• MalfunctionMay 13, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 12X40X75MM EPIC STENT WAS SELECTED HOWEVER, PART OF THE STENT WAS EXPOSED WHEN IT WAS REMOVED FROM THE PACKAGING. WHEN ATTEMPTED TO FIX, THE STENT WAS INADVERTENTLY DEPLOYED. IT WAS NOT USED IN PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8605839 ↗
• MalfunctionApr 12, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT WAS INADVERTENTLY DEPLOYED. THE TARGET LESION WAS LOCATED AT ILIAC ARTERY. DURING PREPARATION OF A 12X40X75 EPIC VASCULAR STENT, IT WAS NOTICED THAT THE STENT WAS ALREADY DEPLOYED. THE THUMBWHEEL LOCK HAD NOT BEEN REMOVED. THE DEVICE WAS NOT USED ON THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 6CM EPIC STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8509862 ↗
• MalfunctionNov 21, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR 2134265-2017-11938. IT WAS REPORTED THE CATHETER WAS STUCK ON THE WIRE. A 12X40X75 EPIC¿ VASCULAR STENT WAS SELECTED FOR A AORTAGRAM WITH RUNOFF PROCEDURE IN THE COMMON ILIAC ARTERY. THE STENT WAS DEPLOYED SUCCESSFULLY. UPON REMOVING THE STENT FROM THE .035 AMPLATZ WIRE, THE STENT CATHETER WAS STUCK TO THE GUIDEWIRE. THE WIRE AND DEVICE WERE ALL REMOVED TOGETHER AS ONE UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS REPORTED AS OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049149 ↗
• MalfunctionDec 2, 2016Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AFTER A 0.018 INCH NON-BSC GUIDE WIRE CROSSED THE LESION AND PRE-DILATATION WAS PERFORMED WITH A 4MM BALLOON CATHETER, A 12X40X75 EPIC¿ VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DISTAL TIP OF THE DEVICE WAS CAUGHT BY THE CALCIFICATION AND AN EXISTING COIL IN THE LESION, AND THE DEVICE FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE TIP PORTION OF THE STENT STRUTS WERE FOUND TO BE LIFTED UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6142311 ↗