Epic VascularRecalls & reported problems across all models

We found 50 models of Epic Vascular by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 213 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 4, 2026 — classified as 3 deaths, 65 injuries, 145 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Epic Vascular problems

Epic Vascular models

50 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Epic™ Vascular H74939200104070

  STENT, ILIAC
  18 reports
• Epic™ Vascular H74939200108070

  STENT, ILIAC
  1 death12 reports
• Epic™ Vascular H74939200086020

  STENT, ILIAC
  11 reports
• Epic™ Vascular H74939200124070

  STENT, ILIAC
  10 reports
• Epic™ Vascular H74939200084070

  STENT, ILIAC
  10 reports
• Epic™ Vascular H74939200088020

  STENT, ILIAC
  10 reports
• Epic™ Vascular H74939200126070

  STENT, ILIAC
  9 reports
• Epic™ Vascular H74939200061220

  STENT, ILIAC
  9 reports
• Epic™ Vascular H74939200106070

  STENT, ILIAC
  7 reports
• Epic™ Vascular H74939200101070

  STENT, ILIAC
  7 reports
• Epic™ Vascular H74939200094070

  STENT, ILIAC
  7 reports
• Epic™ Vascular H74939200104020

  STENT, ILIAC
  6 reports
• Epic™ Vascular H74939200061020

  STENT, ILIAC
  5 reports
• Epic™ Vascular H74939200066020

  STENT, ILIAC
  5 reports
• Epic™ Vascular H74939200071070

  STENT, ILIAC
  5 reports
• Epic™ Vascular H74939200084020

  STENT, ILIAC
  5 reports
• Epic™ Vascular H74939200088070

  STENT, ILIAC
  5 reports
• Epic™ Vascular H74939200074070

  STENT, ILIAC
  4 reports
• Epic™ Vascular H74939200081020

  STENT, ILIAC
  1 death4 reports
• Epic™ Vascular H74939200086070

  STENT, ILIAC
  1 death4 reports
• Epic™ Vascular H74939200098070

  STENT, ILIAC
  4 reports
• Epic™ Vascular H74939200106020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200108020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200124020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200068020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200074020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200076020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200071020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200081070

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200098020

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200091070

  STENT, ILIAC
  3 reports
• Epic™ Vascular H74939200101020

  STENT, ILIAC
  2 reports
• Epic™ Vascular H74939200126020

  STENT, ILIAC
  2 reports
• Epic™ Vascular H74939200078020

  STENT, ILIAC
  2 reports
• Epic™ Vascular H74939200078070

  STENT, ILIAC
  2 reports
• Epic™ Vascular H74939200081220

  STENT, ILIAC
  2 reports
• Epic™ Vascular H74939200081270

  STENT, ILIAC
  2 reports
• Epic™ Vascular H74939200096070

  STENT, ILIAC
  2 reports
• Epic™ Vascular H74939200103020

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200123070

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200064020

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200066070

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200071220

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200071270

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200076070

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200083020

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200092020

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200093020

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200094020

  STENT, ILIAC
  1 report
• Epic™ Vascular H74939200096020

  STENT, ILIAC
  1 report

Recent Epic Vascular adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600727 ↗
• 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 ↗
• MalfunctionMay 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MARKERBAND ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC ARTERY. A 10MM X 40MM X75 EPIC? VASCULAR SELF-EXPANDING STENT WAS PLACED IN THE PROXIMAL ILIAC, FOLLOWED BY A 10MM X 50MM NON-BOSTON SCIENTIFIC STENT PLACED DISTAL TO THE FIRST STENT, AND FINALLY AN 8X40X75 EPIC? VASCULAR SELF-EXPANDING STENT WAS PLACED DISTAL TO THE NON-BSC STENT. AFTER STENTING, ANGIOGRAPHY CONFIRMED PATENT FLOW THROUGH THE ILIAC ARTERY WITH NO CONCERNS. HOWEVER, A POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT ONE OF THE FIVE RADIOPAQUE (RO) MARKER BANDS AT THE DISTAL END OF AN EPIC STENT APPEARED IN THE CENTER OF THE VESSEL. THIS WAS NOTED TO BE ABNORMAL BASED ON IMAGING THAT THE RO BAND WOULD NOT BE OPPOSED TO THE VESSEL WALL. THERE WERE NO PLANS TO REMOVE THE STENTS, AND THE PATIENT WAS SCHEDULED FOR DUPLEX ULTRASOUND IN TWO WEEKS TO CONFIRM CONTINUED BLOOD FLOW. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117923 ↗
• 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 ↗
• MalfunctionMar 3, 2026Positioning Problem

  IT WAS REPORTED THAT STENT JUMPING OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 9X40X75 EPIC STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, STENT JUMPING OCCURRED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497230 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 16, 2025Break; Entrapment of Device; Difficult to Advance; Break; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. VASCULAR ACCESS WAS VIA A RIGHT COMMON FEMORAL ARTERY (CFA) CONTRALATERAL APPROACH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 10X60X75 EPIC SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, ANGLE OF THE ABDOMINAL AORTIC BIFURCATION WAS STEEP, THE GUIDING SHEATH WAS ACHIEVED UP TO PRE-DILATION, THOUGH NAVIGATION WAS CHALLENGING. WHEN INTRODUCING THE DEVICE, RESISTANCE AND STIFFNESS WERE NOTED, PROMPTING CAREFUL MANIPULATION; HOWEVER, IT COULD NOT REACH THE LESION. ATTEMPTS TO RETRIEVE THE DEVICE FAILED, REQUIRING REMOVAL OF BOTH THE DEVICE AND GUIDEWIRE TOGETHER. EXAMINATION REVEALED A FRACTURED PROXIMAL SHAFT, RENDERING THE DEVICE UNUSABLE. THERE WAS NO PROCEDURAL FACTORS CONTRIBUTE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822331 ↗
• MalfunctionDec 2, 2025Contamination; Incomplete or Missing Packaging; Contamination; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE STENT WAS NOT IN A SEALED STERILE PACKAGE.THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER LEG. A 6X80X120 EPIC VASCULAR WAS SELECTED FOR RIGHT LOWER LEG ANGIOGRAPHY. HOWEVER, IT WAS NOTED THAT THE STENT WAS IN AN UNOPENED BOX BUT NOT IN A SEALED STERILE PACKAGE. THE DEVICE WAS IMMEDIATELY SET ASIDE AS SOON AS THE BOX WAS OPENED AND WAS NEVER INTRODUCED TO 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 23695620 ↗
• MalfunctionNov 26, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED PORTAL VEIN. AN 8X60X75 EPIC VASCULAR STENT SELF-EXPANDING WAS SELECTED FOR USE. UPON INSERTION OF THE STENT INTO THE LESION THROUGH THE 7FR SHEATH, THE OUTER SHAFT RETRACTED BEFORE REACHING THE TARGET LESION, CAUSING THE STENT TO BEGIN TO DEPLOY. THE USE OF THE STENT WAS DISCONTINUED BEFORE IT COULD BE PRESSED AGAINST THE VESSEL. 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 23660670 ↗
• MalfunctionNov 24, 2025Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2025. IT WAS REPORTED THAT SHAFT KINKED OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 12X60X120 EPIC STENT SELF EXPANDING WAS SELECTED FOR ANGIOPLASTY OF ILIAC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE TIP OF THE DELIVERY DEVICE WAS KINKED, AND THE GUIDE WIRE COULD NOT CROSS THE DELIVERY DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIALLY DEPLOYED STENT. IT WAS FURTHER REPORTED THAT THE STENT WAS DEPLOYED INADVERTENTLY DURING TRANSIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633656 ↗
• MalfunctionOct 31, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. AN 8 X 40 X 75 EPIC STENT SELF-EXPANDING WAS SELECTED FOR ENDOVASCULAR TREATMENT TO TREAT LOWER EXTREMITY ARTERY DISEASE. DURING THE PROCEDURE, A CONTRALATERAL APPROACH WAS USED. AFTER PLACEMENT WITH A NON-BOSTON SCIENTIFIC INTRODUCER SHEATH FROM THE LEFT FEMORAL ARTERY, THE STENT WAS ADVANCED DIRECTLY TO THE LESION PART. HOWEVER, THE TIP OF THE STENT GOT STUCK DURING ADVANCEMENT, WHICH RESULTED IN A KINK FROM THE MID-SHAFT TOWARDS THE SIDE OF THE TIP. THE PHYSICIAN COULD NOT FULLY DETERMINE WHERE IT GOT STUCK AND KINKED AS THE STENT ADVANCED QUICKLY. 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 23437822 ↗
• 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 ↗

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