Epic™ Vascular H74939200104070Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729805014), received between Jun 9, 2017 and Jun 30, 2026 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT ILIAC ARTERY. A 10X40X75 EPIC STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, PRE-DILATION WAS PERFORMED WITH A MUSTANG BALLOON CATHETER VIA A CONTRALATERAL LEG APPROACH, AND IT WAS CONFIRMED THAT DILATION WAS ABLE TO BE PERFORMED. AFTER THAT, A STENT WAS INSERTED, AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT BY TURNING THE HANDLE AT THE LESION SITE, BUT THE STENT DID NOT DEPLOY EVEN WHEN THE TIP BEGAN TO EMERGE. DILATION WAS ATTEMPTED THROUGH THE STENT USING A BALLOON, BUT THE BALLOON COULD NOT BE INSERTED WITHIN THE STENT, SO IT WAS DISCONTINUED. THE DEVICE WAS REMOVED, AND THERE WERE NO SEPARATION/BREAKAGE OBSERVED IN THE REMOVED STENT. 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 25673531 ↗
• MalfunctionNov 14, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE. A 10X40X75 EPIC VASCULAR WAS UNPACKED. THERE WERE NO VISIBLE TEAR OR HOLE IN THE PACKAGING, HOWEVER, A HUMAN HAIR WAS FOUND ON THE HANDLE OF THE STENT DEPLOYMENT SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136373 ↗
• InjuryAug 28, 2023Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION. THE TARGET LESION WAS LOCATED IN ILIAC ARTERY. A 10X40X75 EPIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON INITIAL DEPLOYMENT OF THE STENT, THE STENT JUMPED FORWARD AND DEEPER INTO THE AORTA THAN INTENDED. THE PHYSICIAN THEN TRIED TO PULL BACK THE STENT BUT WITH MORE THAN HALF OF THE STENT BEING DEPLOYED IT COULD NOT BE PULLED BACK OR REPOSITIONED. HENCE, THE PHYSICIAN DECIDED TO PLACE ANOTHER STENT IN OSTIUM ILIAC LESION TO HELP PRESERVE THE ILIAC BIFURCATION. MOREOVER, THE STENT WAS FULLY OPPOSED TO THE VESSEL WALL POST-PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637296 ↗
• InjuryMay 12, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE POST-DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING AN IPSILATERAL RETROGRADE PUNCTURE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT COMMON ILIAC ARTERY. THE LESION LENGTH WAS SLIGHTLY LESS THAN 4CM. AFTER A 235CM JUPITER SFC GUIDEWIRE AND A 6F NON-BOSTON SCIENTIFIC GUIDE CATHETER WERE ADVANCED, PRE-DILATATION WAS PERFORMED WITH AN 8.0X20 STERLING MR BALLOON CATHETER. SUBSEQUENTLY, A 10X40X75 EPIC VASCULAR STENT WAS DEPLOYED AND POST DILATATION WAS PERFORMED USING A 10.0X40 NON-BOSTON SCIENTIFIC BALLOON. INTRAVENOUS ULTRASOUND CONFIRMED THE STENT WAS PROPERLY APPOSED TO THE VESSEL WALL. HOWEVER, WHEN THE NON-BSC GUIDE CATHETER WAS MOVED UP FOR FINAL IMAGING, THE STENT GOT CAUGHT CAUSING THE DISTAL EDGE TO LIFT AND SHORTEN. BALLOON DILATATION WAS THEN ATTEMPTED WITH THE 8.0X20 STERLING MR BALLOON CATHETER, HOWEVER SUFFICIENT DILATATION COULD NOT BE OBTAINED. A 10.0X40 NON-BSC BALLOON WAS ATTEMPTED TO BE USED BUT IT COULD NOT BE INSERTED INSIDE THE STENT. A 4.0X40 NON-BSC BALLOON WAS ALSO USED BUT SUFFICIENT DILATATION STILL COULD NOT BE OBTAINED. SINCE GOOD BLOOD FLOW WAS OBSERVED, NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918435 ↗
• MalfunctionFeb 16, 2023Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 10X40X75 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE SHIPPING BOX WAS OPENED, IT WAS NOTICED THAT THE INNER POUCH HAS A HOLE AND THE DEVICE INSIDE WAS BENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387397 ↗
• InjuryFeb 3, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT EXPANSION FAILURE OCCURRED. THE 100% TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND NON-CALCIFIED BILIARY ARTERY. A 10X40X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE RADIAL FORCE WAS INSUFFICIENT REQUIRING ADDITIONAL BALLOONING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294627 ↗
• InjurySep 9, 2022Positioning Problem; Migration; Positioning Problem; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT SUBCLAVIAN ARTERY. A NON-BOSTON SCIENTIFIC SHEATH WAS GUIDED PROXIMALLY TO THE LEFT SUBCLAVIAN ARTERY LESION BY LEFT BRACHIAL ARTERY PUNCTURE. SINCE THE STENOSIS RATE WAS MILD, A 10X40X75MM EPIC STENT WAS DEPLOYED IN LEFT SUBCLAVIAN ARTERY WITHOUT PREDILATION. HOWEVER, ANGIOGRAPHY AFTER IMPLANTATION SHOWED THAT THE DISTAL END OF THE STENT HAD PROTRUDED INTO THE INFERIOR AORTIC ARCH. A 9FR SHEATH WAS GUIDED FROM THE RIGHT FEMORAL ARTERY TO THE PROXIMAL PART OF THE STENT, AND THE STENT WAS PULLED IN WITH A SNARE TO THE RIGHT COMMON ILIAC ARTERY. IT WAS PLANNED TO BE REMOVED THROUGH AN OPEN WOUND, BUT DUE TO A DROP IN BLOOD PRESSURE, IT WAS DECIDED TO MOVE THE PATIENT FROM THE ANGIOGRAPHY ROOM TO THE OPERATING ROOM AFTER A COMPUTERIZED TOMOGRAPHY (CT) SCAN TO PERFORM THE PROCEDURE. AFTER COIL EMBOLIZATION OF THE POSTERIOR PANCREATIC DUODENAL ARTERY DUE TO BLEEDING IN THE ABDOMINAL CAVITY ON THE CT SCAN, THE PHYSICIAN SUGGESTED THAT AN OPEN WOUND REMOVAL WOULD BE DIFFICULT, SO AN APPOSITION WAS PERFORM WITH A STENT GRAFT AND COMPLETED THE PROCEDURE. THE BLEEDING IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391718 ↗
• InjuryJul 13, 2021Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ILIAC ARTERY. FOLLOWING PRE-DILATION WITH A 9MM MUSTANG BALLOON CATHETER, A 10X40X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT STENT JUMPING OCCURRED WHEN DEPLOYING THE STENT ABOUT 1MM. THE STENT WAS DEPLOYED AND WAS FULLY APPOSED WHERE IT WAS SUPPOSED TO BE DEPLOYED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162329 ↗
• InjuryMay 5, 2021Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE PATIENT PRESENTED FOR ARTERIOVENOUS FISTULA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED BRACHIAL VEIN. A 10X40X75 EPIC VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, THE STENT JUMPED AND MIGRATED. THE STENT WAS IMPLANTED MORE ON THE CEPHALIC VEIN ON THE DISTAL SIDE THAN ORIGINALLY INTENDED. A SECOND STENT WAS ADVANCED BY A WIRE PASSING THROUGH THE FIRST STENT, AND WAS IMPLANTED ON THE LESION THAT WAS NOT COVERED BY THE FIRST STENT. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS WELL MAINTAINED AFTER THE PROCEDURE WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777477 ↗
• MalfunctionFeb 25, 2021Mechanical Problem; Mechanical Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-FEB-2021. IT WAS REPORTED THAT SAFETY LOCK WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN. A 10X40X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE INITIATING DEPLOYMENT, THE YELLOW LOCKING TAB BROKE. THE PHYSICIAN WAS NOT ABLE TO TURN THE THUMBWHEEL THUS THE STENT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT PARTIAL DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11380624 ↗
• MalfunctionJan 27, 2021Entrapment of Device; Difficult to Remove; Difficult to Advance; Material Deformation; Entrapment of Device; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS ENTRAPPED ON THE GUIDEWIRE AND DIFFICULT TO REMOVE. THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. AFTER CROSSING THE LESION WITH A NON-BSC GUIDEWIRE, PRE-DILATATION WAS PERFORMED WITH A STERLING BALLOON CATHETER. SUBSEQUENTLY, A 10X40X75 EPIC STENT WAS ADVANCED BUT COULD NOT ADVANCE THROUGH THE TORTUOUS VESSEL BEFORE THE LESION. THE GUIDEWIRE WAS REPLACED WITH ANOTHER NON-BSC GUIDEWIRE BUT IT WAS STUCK IN THE LUMEN AND THE EPIC STENT WAS DIFFICULT TO REMOVE FROM THE INTRODUCER SHEATH. THE DEVICE WAS REMOVED, LUMEN WAS FLUSHED AGAIN, AND THEN BROUGHT TO THE LESION WITH ANOTHER GUIDEWIRE BUT THE SAME ISSUE OCCURRED. IT WAS DETERMINED THAT THE LUMEN WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11237580 ↗
• InjuryJan 27, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC. AFTER CROSSING THE LESION WITH A 0.035 GUIDEWIRE, PRE-DILATATION WAS PERFORMED. SUBSEQUENTLY, A 10X40X75 EPIC STENT SELF EXPANDING WAS USED FOR TREATMENT. HOWEVER, SHORTENING OCCURRED UNEXPECTEDLY, AND LESION COULD NOT BE COVERED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INJURY REPORTED. IT WAS FURTHER REPORTED THAT THE SIZE OF THE STENT WAS CONFIRMED PRIOR TO THE PROCEDURE AND FORESHORTENING DETERMINED WHEN THE CELL SPACING OF THE STENT BECAME NARROWER DURING THE TIME OF STENT DEPLOYMENT. THE STENT WAS COMPLETELY DEPLOYED AND THE PHYSICIAN USED AN ELUVIA STENT TO COVER THE REMAINING LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11237127 ↗
• InjuryJan 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE NON-SIGNIFICANTLY TORTUOUS TARGET LESION WAS LOCATED IN THE ILIAC VESSEL. A 10X40X75 EPIC VASCULAR STENT WAS IMPLANTED TO TREAT THE LESION. A SIGNIFICANT AMOUNT OF FORESHORTENING OF THE STENT OCCURRED. ANOTHER STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11119045 ↗
• MalfunctionDec 14, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. A 10X40X75 EPIC VASCULAR STENT WAS ADVANCED AND DEPLOYED. THE STENT JUMPED ABOUT A CENTIMETER AFTER IT WAS DEPLOYED. THE LESION WAS FULLY COVERED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11003944 ↗
• InjurySep 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 10X40X75 EPIC VASCULAR STENT WAS DEPLOYED. HOWEVER, DURING THE USE OF A TOUCH UP BALLOON, IT WAS NOTED THAT THE EDGE OF THE STENT GOT CAUGHT AND FLATTENED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available

  MAUDE report 10489892 ↗
• InjuryJun 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 10X40X75 EPIC (EPIC VASCULAR) STENT WAS SELECTED FOR USE. DURING DEPLOYMENT, THE PHYSICIAN INTENDED TO APPLY TENSION PROPERLY DURING DEPLOYMENT; HOWEVER, THE DEVICE WAS EVENTUALLY SHORTENED. SUBSEQUENTLY, AN ADDITIONAL STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184103 ↗
• MalfunctionOct 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT EXTERNAL ILIAC ARTERY. A 10X40X75MM EPIC STENT WAS ADVANCED TO TREAT THE LESION VIA A CONTRALATERAL APPROACH. HOWEVER, DURING DEPLOYMENT, THE OUTER SHEATH WAS TRAPPED BY CALCIFICATION PREVENTING SUCCESSFUL DEPLOYMENT LEADING THE STENT TO BE PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9196784 ↗
• MalfunctionJun 9, 2017Bent; Difficult or Delayed Positioning; Bent; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES AND STENT DAMAGED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. THE 10X40X75MM WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE OUTER SHEATH BECAME CAUGHT WHICH RESULTED IN DAMAGING THE EPIC¿ STENT. THE EPIC¿ WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 9X40MM EPIC¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6629524 ↗