Cordis S.M.A.R.T. Control Vascular Stent System C06060SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032023556), received between Apr 18, 2017 and Apr 18, 2017 — classified as 1 injury.

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.

• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS WAS CONFIRMED IN A (B)(6) -YEAR-OLD FEMALE PATIENT, WHO HAD A SMART CONTROL STENT PREVIOUSLY PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. THE TARGET LESION WAS THE MIDDLE PORTION OF THE LEFT FEMORAL ARTERY. THE PATIENT¿S VESSEL WAS NOT TORTUOUS AND HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS 90 %. OVER TWO YEARS AFTER THE PROCEDURE, IT WAS CONFIRMED THAT THE PATIENT EXPERIENCED INTERMITTENT CLAUDICATION ON THE LEFT LEG. AORTOGRAPHY (AOG) CONFIRMED THE STENOSIS IN THE PROXIMAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ANKLE-BRACHIAL INDEX (ABI) WAS 0.07 ON THE RIGHT LEG AND 0.59 ON THE LEFT PRIOR TO THE REVASCULARIZATION PROCEDURE. THE RUTHERFORD LEVEL WAS 2 ON THE RIGHT AND 3 ON THE LEFT. REVASCULARIZATION WAS PERFORMED AT THE SITE OF STENOSIS. A SMART STENT WAS DEPLOYED IN THE PROXIMAL PORTION OF THE TARGET LESION AND BALLOON INFLATION WAS DONE WITH A SABER BALLOON. THE PATIENT RECOVERED AFTER THE PROCEDURE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: Reocclusion; Vascular System (Circulation), Impaired

  MAUDE report 6500012 ↗

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