Cordis S.M.A.R.T. Control Vascular Stent System C06080SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032023594), received between Aug 8, 2018 and Aug 8, 2018 — 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.

• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, APPROXIMATELY FIVE YEARS POST IMPLANTATION OF A SMART (SMART CONTROL, ILIAC 6X80) SELF¿EXPANDING STENTS (SES) ON THE MIDDLE PORTION OF THE LEFT FEMORAL ARTERY, THE PATIENT DEVELOPED IN-STENT RESTENOSIS CONFIRMED BY AN ECHOGRAPHY. THEN, A REVASCULARIZATION WAS PERFORMED IN THE MIDDLE PORTION OF THE LEFT FEMORAL ARTERY AND A NON-CORDIS STENT WAS IMPLANTED. TWENTY-SEVEN DAYS, THE PATIENT RECOVERED. THE EVENT WAS NOT RELATED WITH THE CORDIS PRODUCT.

  Patient problems: Reocclusion

  MAUDE report 7762597 ↗

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