S.M.A.R.T. C14080SBRecalls & reported problems
Cordis Corporation · SMART 7FR 80CM BILIARY 14X80 · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032025055), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- Cardiac Tamponade1
- Chest Pain1
- Foreign Body In Patient1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2018Migration or Expulsion of Device
A TRANSHEPATIC BILIARY SELF-EXPANDABLE SMART CONTROL STENT (7FR 14MM X 80MM) WAS INSERTED INTO THE PATIENT'S LEFT ILIAC VEIN IN OUR INTERVENTIONAL RADIOLOGY SUITE. THREE HOURS LATER THE PATIENT RETURNED TO OUR IR SUITE WITH CHEST PAIN. UNDER FLUOROSCOPY IT WAS DISCOVERED THAT THE STENT HAD MIGRATED TO THE INFERIOR VENA CAVA-RIGHT ATRIAL JUNCTION. LIFE-SAVING INTERVENTIONS WERE REQUIRED TO REMOVE THE STENT. THE PATIENT HAD COMPLICATIONS OF CARDIAC EFFUSION/TAMPONED, WHICH REQUIRED LIFE SAVING SURGERY.
Patient problems: Cardiac Tamponade; Chest Pain; Foreign Body In Patient; Pericardial Effusion
MAUDE report 7604841 ↗
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- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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