Cordis S.M.A.R.T. Control Vascular Stent System C07040SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032023815), received between Dec 16, 2016 and Mar 20, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionMar 20, 2017Material Frayed; Material Frayed

  AS REPORTED THE SMART CONTROL, ILIAC 7 X 40 STENT WAS ATTEMPTED TO BE PLACE AT THE LESION BUT THERE WAS RESISTANCE FELT. THE PHYSICIAN APPLIED THE FORCE TO ADVANCE THE STENT. THEREFORE ADDITIONAL PRE-DILATION WAS CONDUCTED BY A BALLOON CATHETER (SABER). THE STENT WAS RE-ADVANCED TO THE LESION BUT ITS DISTAL TIP GOT FRAYED AND KINKED. THEREFORE THE STENT WAS REPLACED WITH ANOTHER ONE OF THE SAME SIZE. ADDITIONAL PRE-DILATION WAS PERFORMED AND THE STENT WAS PLACED. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY FOR STENOTIC LESION. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. AN IPSILATERAL APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. THE MICRO CATHETER (PROMINENT, TOKAI MEDICAL) WAS USED FOR BACKUP AND GUIDEWIRE (ASTATO XS/CHEVALIER 14 TAPERED 30 ) WERE CROSSED THE LESION. PRE-DILATION WAS PERFORMED BY BALLOON (COYOTE, BOSTON SCIENTIFIC).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6419124 ↗
• MalfunctionDec 16, 2016Crack; Crack

  AS REPORTED BY THE AFFILIATE, BREAKAGE OF A SMART CONTROL STENT WAS CONFIRMED DURING OR AFTER FLUSHING PRIOR TO USE. IT WAS REPLACED WITH A NEW SMART CONTROL STENT OF A DIFFERENT SIZE TO COMPLETE THE PROCEDURE. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT CLINICALLY USED AND IT WILL BE RETURNED FOR ANALYSIS. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6182721 ↗

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