Cordis S.M.A.R.T. Control Vascular Stent System C08080SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032024195), received between Mar 9, 2017 and Mar 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

4 other recalls cover devices cleared under the same FDA submission (P020036, P120002); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2017Material Frayed; Physical Resistance; Difficult to Advance; Torn Material; Material Frayed; Physical Resistance; Difficult to Advance; Torn Material

  IT WAS REPORTED THAT AFTER A GUIDEWIRE CROSSED THE LESION THE SMART CONTROL STENT WAS DELIVERED BUT RESISTANCE WAS FELT. THE STENT WAS REMOVED AND IT WAS CONFIRMED THAT THE DISTAL TIP PART AND THE TIP SHAFT PART GOT FRAYED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO CALCIFICATION CONFIRMED. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS ILIAC ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU AND THE DEVICE PREPPED NORMALLY. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. THE STENT WAS REPLACED WITH ANOTHER ONE OF A DIFFERENT LOT NUMBER. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390847 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020036, P120002. One submission often covers many models, so check the product and lot details in each record.

• Z-1510-2025 · Mar 4, 2025 · Open, Classified
  Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
• Z-0728-2020 · Nov 14, 2019 · Open, Classified
  S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy)
• Z-1040-2012 · Jan 31, 2012 · Terminated
  S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic a
• Z-1556-2008 · Mar 10, 2008 · Terminated
  CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in patients with symptomatic atheroscler