Cordis S.M.A.R.T. Control Vascular Stent System C10040SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032024614), received between Jul 10, 2017 and Feb 4, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 10X40 SMART CONTROL ILIAC SELF-EXPANDING STENT (SES) WAS INSERTED AND DELIVERED AFTER A NON-CORDIS GUIDEWIRE HAD CROSSED THE LESION. THE LOCKING PIN OF THE SMART STENT WAS RELEASED AND THE COMPLAINT STENT WAS STARTED TO BE DEPLOYED WITH THE TUNING DIAL. HOWEVER, THE OUTER WAS NOT ABLE TO BE SLID. THE SLID LEVER WAS WITHDRAWN BUT THE SAME ISSUE CONTINUED. BEING DEPLOYED APPROXIMATE 10 CM FROM THE DISTAL END ALREADY, THE COMPLAINT SMART STENT WAS REMOVED FROM THE PATIENT SLOWLY. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART CONTROL PRODUCT (10X40). THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS AT THE RIGHT ILIAC ARTERY AND A CROSS-OVER APPROACH WAS MADE. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO CONFIRM THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS BEING DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664287 ↗
• MalfunctionOct 4, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 10X40 ILIAC SMART CONTROL STENT WAS ATTEMPTED TO BE DELIVERED, HOWEVER THE STENT COULD NOT CROSS THE LESION. NO PATIENT INJURY WAS REPORTED. THE TARGET LESION HAD BOTH SEVERE TORTUOUSITY AND ANGULATION, WAS SEVERELY CALCIFIED, AND WAS LOCATED BETWEEN THE COMMON ILIAC ARTERY AND THE EXTERNAL ILIAC ARTERY. THE PERCENTAGE OF STENOSIS WAS NINETY-NINE PERCENT AND THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED IN A DEVICE STORAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND PREPPED NORMALLY, AND THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE STENT WAS NOT MANIPULATED DURING PREP. IT WAS VERIFIED PRIOR TO INSERTION THAT THE STENT WAS CONTAINED WITHIN THE OUTER SHEATH/INTRODUCER OF THE SYSTEM. THE GUIDEWIRE PORT FLUSHED AS OUTLINED IN THE IFU PRIOR TO LOADING ON THE GUIDEWIRE. THE CONCOMITANT SHEATH WAS NON-CORDIS. AN IPSILATERAL APPROACH WAS MADE THROUGH THE COMMON FEMORAL ARTERY (CFA). A NON-CORDIS BALLOON CATHETER WAS INSERTED AND INFLATED FOR PRE-DILATION AFTER A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THEN, ANOTHER NON-CORDIS BALLOON CATHETER WAS INSERTED AND INFLATED TO A GREATER SIZE, AND THE SMAR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7935067 ↗
• MalfunctionJul 10, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE SMART CONTROL, ILIAC 10X40 STENT WAS INSERTED IN A SHEATH AND ADVANCED WITH A SUPPORT OF A GUIDEWIRE. THEN, THE STENT FELL INTO THE AORTA. STENT WAS REMOVED BY A SNARE CATHETER. A NEW SMART CONTROL STENT WAS IMPLANTED IN THE TARGET LESION AND THE PROCEDURE WAS COMPLETED. SINCE A PART OF THE CAROTID ARTERY HAS BEEN COVERED WITH A STENT, IN HASTE IT WAS DECIDED TO IMPLANT A STENT IN THE COMMON CAROTID ARTERY BY MAKING AN APPROACH FROM THE NECK. WHEN THE PHYSICIAN WAS FIXING THE POSITION OF THE COMPLAINT STENT, IT WAS DELIVERED TO THE AORTA SIDE FIRST, THEN IT WAS DRAWN BACK. THERE WAS NO RESISTANCE FELT. THE PHYSICIAN COMMENTED THAT IT WAS UNKNOWN HOW AND WHY THE COMPLAINT STENT HAS FALLEN OFF. ADDITIONALLY THAT IT MIGHT HAVE BEEN THE PREVIOUSLY IMPLANTED STENT THAT HAD CAUGHT THE COMPLAINT STENT AND CAUSED THIS INCIDENT. THIS WAS A STENT GRAFT TAA CASE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THERE WERE NO ANOMALIES CONFIRMED PRIOR TO AND DURING THE PROCEDURE. THE PATIENT¿S INFORMATION, TARGET LESION, PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS, CALCIFICATION AND RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS STOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6698940 ↗

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