Cordis S.M.A.R.T. Control Vascular Stent System C07080SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032023891), received between Aug 2, 2017 and Aug 2, 2017 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE AND A HALF YEARS AFTER THE IMPLANTATION OF TWO SMART CONTROL STENTS THE PATIENT¿S ANKLE-BRACHIAL INDEX (ABI) DECREASED AND AN OCCLUSION WAS CONFIRMED IN THE RIGHT COMMON FEMORAL ARTERY. A TARGET LESION REVASCULARIZATION (TLR) WAS PERFORMED AND THE PATIENT RECOVERED ON THE SAME DAY. THE PATIENT WAS AN (B)(6) MALE. THE PATIENT¿S WEIGHT WAS (B)(6). THE INDEX TARGET LESION WAS FROM THE PROXIMAL PORTION TO THE MIDDLE PORTION OF THE RIGHT FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN.

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

  MAUDE report 6760892 ↗
• InjuryAug 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE AND A HALF YEARS AFTER THE IMPLANTATION OF TWO SMART CONTROL STENTS THE PATIENT¿S ANKLE-BRACHIAL INDEX (ABI) DECREASED AND AN OCCLUSION WAS CONFIRMED IN THE RIGHT COMMON FEMORAL ARTERY. A TARGET LESION REVASCULARIZATION (TLR) WAS PERFORMED AND THE PATIENT RECOVERED ON THE SAME DAY. THE PATIENT WAS AN (B)(6). THE PATIENT¿S WEIGHT WAS (B)(6). THE INDEX TARGET LESION WAS FROM THE PROXIMAL PORTION TO THE MIDDLE PORTION OF THE RIGHT FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN.

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

  MAUDE report 6760793 ↗

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