Cordis S.M.A.R.T. Control Vascular Stent System C06100MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032023624), received between Aug 17, 2017 and Jan 28, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE WHITE TUBE IN THE 6MM X 100MM SMART CONTROL STENT FELL OFF DURING USE. THE STENT WAS DEPLOYED AND THE LUER HUB FELL OFF AFTER THE STENT WAS DELIVERED CORRECTLY, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER THE LABELING. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE AND THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE DEVICE WAS PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS MILDLY CALCIFIED. THE VESSEL HAD LITTLE TORTUOSITY WITH 90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE MALFUNCTION WAS NOTED DURING USE. THE DEVICE WAS INSERTED THROUGH A HEMOSTATIC VALVE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE PRODUCT EVALUATION SHOWED THAT THE INNER SHAFT WAS SEPARATED FROM THE HANDLE. ALSO, A SEPARATED CONDITION OF THE COIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9636431 ↗
• MalfunctionJun 15, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE, WHILE ADVANCING/CROSSING THE TARGET LESION WITH A SMART CONTROL ILIAC 6 X 100 STENT DELIVERY SYSTEM (SDS), THE OUTER SHEATH WAS WITHDRAWN BEFORE CROSSING THE LESION AND THE STENT ALMOST RELEASED. THEREFORE, IT WAS REMOVED FROM THE PATIENT AND REPLACED WITH A SMART 6 X 120 STENT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION/TARGET LESION CHARACTERISTIC INFORMATION WAS NOT KNOWN/PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606482 ↗
• MalfunctionOct 5, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A BALLOON CATHETER (3.0MM) WAS DELIVERED TO THE LESION AND A PRE DILATION WAS PERFORMED. A SMART CONTROL, ILIAC 6X100ML STENT ATTEMPTED TO BE DELIVERED FROM THE IPSILATERAL, HOWEVER, IT COULD NOT CROSS THE LESION. ANOTHER DILATATION WAS PERFORMED WITH THE SAME BALLOON CATHETER, AND THE SMART CONTROL, ILIAC 6X100ML STENT ATTEMPTED TO CROSS THE LESION, BUT THE SAME ISSUE OCCURRED. THE SMART CONTROL, ILIAC 6X100ML STENT WAS REMOVED FROM THE PATIENT AND IT WAS CONFIRMED THAT THERE WAS A SLIGHT GAP BETWEEN ITS INNER SHEATH AND ITS OUTER SHEATH, AND THE STENT WAS SLIGHTLY EXPOSED. THEREFORE IT WAS REPLACED WITH A SAME SIZE NEW NON-CORDIS STENT. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE ILIAC ARTERY. THE PATIENT¿S INFORMATION, PATIENT¿S VESSEL LEVEL OF TORTUOSITY, CALCIFICATION AND RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED PRIOR TO USE. THE PRODUCT WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6914774 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY APPROXIMATELY FOUR YEARS POST STENT IMPLANTATION, A RESTENOSIS WAS CONFIRMED BY DOPPLER ULTRASOUND (DUS) DURING A FOLLOW-UP. NO TREATMENT WAS APPLIED. THE PATIENT GETS FOLLOW UP EXAMINATION. THE ORIGINAL TARGET LESION, PATIENT¿S VESSEL LEVEL OF TORTUOSITY, CALCIFICATION AND THE RATE OF STENOSIS WAS UNKNOWN. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: Reocclusion

  MAUDE report 6802023 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY APPROXIMATELY FOUR YEARS POST STENT IMPLANTATION, A RESTENOSIS WAS CONFIRMED BY DOPPLER ULTRASOUND (DUS) DURING A FOLLOW-UP. NO TREATMENT WAS APPLIED. THE PATIENT GETS FOLLOW UP EXAMINATION. THE ORIGINAL TARGET LESION, PATIENT¿S VESSEL LEVEL OF TORTUOSITY, CALCIFICATION AND THE RATE OF STENOSIS WAS UNKNOWN. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: Reocclusion

  MAUDE report 6801919 ↗

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