Epic™ Vascular H74939200081220Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729805588), received between Aug 6, 2018 and Jun 28, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Difficult to Remove1
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.
MalfunctionJun 28, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 8X120X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT AND WAS DEPLOYED. HOWEVER, THE DEPLOYMENT DEVICE GOT STUCK ON A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE UPON REMOVAL OUT OF THE SHEATH. THE PHYSICIAN HAD TO WORK VERY HARD TO REMOVE THE DEPLOYMENT DEVICE OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH THE INDICATED DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14846655 ↗InjuryAug 6, 2018Defective Component; Defective Component
IT WAS REPORTED THAT STENT ELONGATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE EXTERNAL ILIAC ARTERY. A 8X120X120MM EPIC¿ VASCULAR STENT WAS IMPLANTED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT WAS ELONGATED DURING DEPLOYMENT APPROXIMATELY 160MM TO 170MM AND EXTENDED INTO THE AORTA. THE DEVICE WAS LEFT INSIDE THE PATIENT. THE PHYSICIAN THEN DECIDED TO ADVANCED, A 10X20MM MUSTANG BALLOON CATHETER TO PRESS THE STENT AGAINST THE WALL AND DRAGGED IT BACK DOWN INTO THE COMMON ILIAC ARTERY 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 7753368 ↗
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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