Cordis S.M.A.R.T. Control Vascular Stent System C08040MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032024096), received between Sep 29, 2016 and Aug 15, 2017 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Premature Activation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathAug 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A SMART CONTROL STENT IN THE TARGET LESION WITHOUT ISSUE. THE PATIENT WAS AN (B)(6) FEMALE. HER (B)(6). THE ORIGINAL TARGET LESION WAS THE PROXIMAL PORTION OF THE RIGHT FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. APPROXIMATELY THREE YEARS LATER, THE PATIENT EXPIRED. THE DEATH CERTIFICATE IS UNAVAILABLE AND THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death

  MAUDE report 6793905 ↗
• MalfunctionSep 29, 2016Premature Activation; Premature Activation

  AS REPORTED, THE SMART CONTROL ILIAC 8 X 40 ML. STENT DELIVERY SYSTEM (SDS) WAS TAKEN FROM ITS POUCH TO INSERT INTO A SHEATH INTRODUCER, BUT THE DISTAL TIP OF THE STENT WAS SLIGHTLY DEPLOYED. THE EDGE OF THE STENT WAS EXPOSED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT CLINICALLY USED IN THE PATIENT. THE STENT WAS REPLACED WITH A NEW STENT, AND THE PROCEDURE FINISHED SUCCESSFULLY. A CONTRALATERAL APPROACH WAS MADE. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY, AND THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5987139 ↗

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