Cordis S.M.A.R.T. Control Vascular Stent System C10060MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032024638), received between Nov 28, 2016 and May 5, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionMay 5, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  THE UNKNOWN GUIDEWIRE CROSSED THE LESION AND THE 10MM X 60MM SMART CONTROL SELF-EXPANDING STENT (SES) WAS DELIVERED TO THE LESION. HOWEVER, IT WAS DIFFICULT TO REACH THE LESION. THEREFORE, THE SMART STENT WAS REMOVED, AND THE DISTAL END TIP WAS NOTED TO BE FRAYED. IT WAS REPLACED WITH A NEW SMART STENT BUT WITH A DIFFERENT SIZE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE DEVICE USED IN ENDOVASCULAR THERAPY (EVT) WITH A CONTRALATERAL APPROACH. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE GUIDEWIRE PORT WAS FLUSHED AS OUTLINED IN THE IFU. THE LESION HAD A MODERATE CALCIFICATION, LITTLE VESSEL TORTUOSITY AND HAD A 90 % STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE SELF-EXPANDING STENT (SES) DID NOT PASS THROUGH ANY ACUTE BENDS AND DID NOT PASS THROUGH A PREVIOUSLY PLACED STENT. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH WHEN REMOVED FROM THE TRAY. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026751 ↗
• MalfunctionNov 28, 2016Difficult to Remove; Difficult to Remove

  AS REPORTED, AFTER A NON-CORDIS SHEATH INTRODUCER AND A NON-CORDIS GUIDE WIRE CROSSED THE LESION, THE SMART CONTROL ILIAC 10 X 60 ML. SELF EXPANDING STENT WAS IMPLANTED IN THE TARGET LESION. WHEN THE SHAFT OF THE STENT DELIVERY SYSTEM WAS RETRACTED, THE NON-CORDIS SHEATH INTRODUCER AND THE STENT SHAFT GOT STUCK. SOME FORCE AND TWIST WAS APPLIED, AND FINALLY THEY WERE REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS THE ILIAC ARTERY. THE VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS 100%. THE PRODUCT WAS CLINICALLY USED, AND IT WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN RECEIVED. THERE WERE NO REPORTED ISSUES WITH THE SHEATH INTRODUCER OR THE GUIDEWIRE. NO PIECE OF THE STENT OR THE STENT DELIVERY SYSTEM REMAINED IN THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WERE NO KINKS NOTED ON THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY DURING PREP. ADDITIONAL INVESTIGATIONAL QUESTIONS WERE ANSWERED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6128745 ↗

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