Epic™ Vascular H74939200126070Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729805199), received between Nov 17, 2017 and Sep 10, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED ILIAC ARTERY. DURING PREPARATION FOR THE PROCEDURE, AFTER UNPACKING, IT WAS NOTED THAT THE DISTAL TIP OF THE STENT HAD BEEN COMPRESSED; THEREFORE, THE DEVICE WAS NOT USED. 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 23016933 ↗
• InjuryOct 22, 2024Defective Device; Defective Device

  IT WAS REPORTED STENT WAS SHORTENED AND DID NOT FULLY COVER THE LESION SEGMENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT SUBCLAVIAN VESSEL. A 12X60X75 EPIC VASCULAR STENT SELF-EXPANDING WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE DEVICE WAS TESTED FOLLOWING A PRE-BALLOON INFLATION, BUT THE STENT SHORTENED AND WAS UNABLE TO COVER THE LESION. A DIFFERENT SIZE STENT WAS USED TO COVER THE LESION PART, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509886 ↗
• MalfunctionOct 3, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT ON GUIDEWIRE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 12X60X75 EPIC VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE DEVICE GOT STUCK WITH A 0.035X180CM NON-BOSTON SCIENTIFIC GUIDEWIRE AND CAN NO LONGER BE REMOVED. THE ENTIRE SYSTEM WAS REMOVED 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 15533875 ↗
• InjuryMar 10, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. THE PATIENT PRESENTED WITH CLAUDICATION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ILIAC ARTER. A (B)(4) EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT, HOWEVER, THE DEVICE DID NOT DEPLOY PROPERLY. THE DEVICE WAS UNABLE TO BE FULLY RECONSTRAINED AND WAS CRUMPLED. THE PHYSICIAN SNARED THE DEVICE AND PULLED THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER EPIC VASCULAR STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725890 ↗
• MalfunctionDec 14, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN RIGHT ILIAC ARTERY. AFTER A 0.035X300CM GUIDEWIRE CROSSED THE LESION, A 12X60X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT BUT IT GOT STUCK WITH THE GUIDEWIRE. THE DEVICES WERE COMPLETELY REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005849 ↗
• MalfunctionNov 7, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ILIAC ARTERY. FOLLOWING PRE-DILATION, A 2X60X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT AND THE STENT DEPLOYED. HOWEVER, THE STENT DELIVERY SYSTEM BECAME STUCK WITH THE GUIDEWIRE DURING REMOVAL. THE DEVICE AND WIRE WERE REMOVED FROM THE PATIENT TOGETHER AND THE PROCEDURE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760154 ↗
• MalfunctionMar 25, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. A 12X60X75 EPIC STENT WAS SELECTED FOR USE. HOWEVER, THE STENT WAS PARTIALLY DEPLOYED WHEN REMOVED FROM PACKAGING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569107 ↗
• InjuryDec 10, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT POSITIONING/PLACEMENT PROBLEMS WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL VEIN (IVC). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INFERIOR VENA CAVA. AFTER A 7FR SHEATH WAS INSERTED, A 0.035INC X 150 CM NON-BSC GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. A 12MM X60MM X75CM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON DEPLOYMENT, THE STENT WAS PLACED IN A POSITION SHIFTED TO THE CENTER SIDE FROM THE LESION. THE PHYSICIAN WAS GRABBING THE DELIVERY SHAFT BY FINGER AND THE STENT WAS DEPLOYED BY PUSH-IN. THE STENT STOPPED MOVING ON THE CENTER SIDE OF THE IVC, AND IT WAS DECIDED TO MONITOR THE STATUS. A 12MM X60MM X120CM EPIC VASCULAR STENT WAS ADDITIONALLY PLACED WITH THE USED OF A 0.035INC X 300CM NON-BSC GUIDE WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147119 ↗
• MalfunctionNov 17, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE STENT DELIVERY SYSTEM (SDS) BECAME STUCK ON THE GUIDEWIRE. AN IPSILATERAL RETROGRADE APPROACH WAS USED TO ACCESS THE 99% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY (CIA). A 12X60X75 EPIC¿ VASCULAR STENT AND 0.035 NON-BSC GUIDEWIRE WERE SELECTED FOR USE. WHEN THE STENT WAS DIRECTLY ADVANCED TO THE LESION, THE SDS BECAME STUCK MIDWAY AND COULD NOT CROSS THE LESION. THE SDS AND WIRE WERE REMOVED TOGETHER. THE DEVICES WERE CHECKED OUTSIDE THE BODY AND THERE WAS SOME "UNUSUAL FEELING IN THE PASSABILITY". A NEW WIRE AND A 12X60X120 EPIC STENT WERE USED TO COMPLETE THE PROCEDURE. POST DILATION WAS PERFORMED AND GOOD VASCULAR PATENCY WAS OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7041565 ↗