S.M.A.R.T. RADIANZ SR07150XLRecalls & reported problems
Cordis US Corp. · S.M.A.R.T. RADIANZ Vascular Stent System 7x150mm 190CM · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032082683), received between Feb 23, 2024 and Feb 23, 2024 — classified as 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2024Defective Component; Defective Component
AS REPORTED, A 7MM X 150MM 190CM SMART RADIANZ VASCULAR STENT SYSTEM WAS OBSERVED TO HAVE SHRUNK BY ABOUT 5CM WHEN THE STENT WAS BEING IMPLANTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY. EVEN ON THE ANGIOGRAPHY, IT WAS CLEAR THAT THE STENT WAS SHRUNK. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. AN IPSILATERAL APPROACH WAS MADE. THE TARGET SITE WAS SEVERELY CALCIFIED AND TORTUOUS. THE SITE WAS 99% STENOSED. THERE WAS SEVERE ACUTE ANGULATION OF THE VESSEL AND MODERATE BIFURCATION. THERE WAS NOT A CHRONIC TOTAL OCCLUSION AT THE TARGET SITE. THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE DEVICE OR PACKAGING PRIOR TO USE IN THE PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18767768 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- 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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