Epic™ Vascular H74939200078020Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent System · Class 3
All models of Epic Vascular (50)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729805526), received between Aug 2, 2019 and Mar 18, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Activation Failure” (1 report).
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
Device problems
- Activation Failure1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2021Migration; Migration
IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE PATIENT UNDERWENT ABDOMINAL AORTOGRAPHY AND ILIAC ARTERY STENTING. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY AND PLACED GUIDEWIRE VESSEL SHEATH. THE MILD DISSECTED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND NON-TORTUOUS VESSEL. THE PHYSICIAN ADVANCED THE GUIDEWIRE AND PIG TAIL ANGIOGRAPHY CATHETER THROUGH THE SHEATH TO INFERIOR VENA CAVA TO PERFORM ANGIOGRAPHY. AFTER AN AMPLATZ5090 GUIDEWIRE WAS PLACED AS SUPPORT, A 7 X 80 X 120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. DURING STENT DEPLOYMENT, IT WAS NOTICED THAT THE STENT WAS DISPLACED FORWARDLY. BECAUSE THE STENT COULD NOT BE CONSTRAINED, IT WAS THEN COMPLETELY DEPLOYED BUT FAILED TO BE DEPLOYED IN ACCURATE LOCATION. THE DEVICE WAS IMPLANTED IN THE LESION AND WAS OVERLAPPED WITH OTHER 7X100 INNOVA STENT TO COVER THE LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11515381 ↗InjuryAug 2, 2019Activation Failure; Activation Failure
IT WAS REPORTED THAT STENT DID NOT FULLY EXPAND POST DEPLOYMENT. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 7X80X120MM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT FAILED TO FULLY EXPAND. SECONDARY STENTING WAS PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8855564 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Omnilink Elite 1012631-59Abbott Vascular Inc. · STENT, ILIAC21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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