Cordis S.M.A.R.T. Control Vascular Stent System C08040SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032024119), received between Nov 8, 2016 and Feb 9, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 8X40 SMART CONTROL STENT WAS INSERTED INTO THE SHEATH TO BE USED FOR THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS MADE WITH A 45CM NON-CORDIS GUIDING SHEATH. THE PHYSICIAN NOTICED THAT THE STENT WAS SLIGHTLY DEPLOYED FLARE FROM THE TIP WHEN THE COMPLAINT DEVICE CAME OUT OF THE SHEATH. IT WAS NOTED THAT APPROXIMATELY 5MM OF THE STENT WAS DEPLOYED. THE COMPLAINT DEVICE WAS REMOVED WITHOUT IMPLANT, BUT THE STENT STRUT GOT CAUGHT ON THE Y-CONNECTOR OF THE CONCOMITANT SHEATH. THE STENT WAS DEPLOYED OUTSIDE THE BODY IN SUCH A WAY THAT THE STENT WAS ENTANGLED WITH THE Y-CONNECTOR FROM THE DELIVERY SYSTEM. CONSIDERING THE POSSIBILITY THAT THE STENT WAS SLIGHTLY DEPLOYED DUE TO CALCIFICATION IN THE ILIAC, THE PHYSICIAN CHANGED TO AN IPSILATERAL APPROACH. THE SHEATH WAS REPLACED WITH A NEW 23CM NON-CORDIS SHEATH AND A SMART STENT (8*30) WAS USED FOR THE SUPERFICIAL FEMORAL ARTERY AND THE PROCEDURE COMPLETED. THE SECOND STENT WAS PLACED WITH AND WAS WELL EXPANDED AND IN GOOD POSITION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO LESION AT THE ILIAC ARTERY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335127 ↗
• MalfunctionJan 16, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, AFTER DEPLOYING THE 8X40 SMART CONTROL STENT, IT WAS NOTED BY THE PHYSICIAN THAT THE DEVICE HAD SOME RESISTANCE WHILE THE DISTAL END OF THE DEVICE WAS BEING WITHDRAWN BACK INTO THE SHEATH. THE PHYSICIAN CONTINUED TO REMOVE THE DEVICE FROM THE PATIENT; HOWEVER, DURING THE REMOVAL, THE WIRE AND SHEATH CAME OUT OF THE VESSEL WITH THE SMART CONTROL. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO THE DEVICE PRIOR TO USE. THE SDS WAS PREPPED PER THE IFU WITHOUT ANY DIFFICULTY. THE STENT WAS NOT MANIPULATED DURING PREP OF THE DEVICE. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED. AN IPSILATERAL RETROGRADE APPROACH WAS USED FOR THE PROCEDURE. THE LESION WAS IN THE ILIAC ARTERY. THE LESION WAS NOTED TO HAVE MILD CALCIFICATION AND A 70% STENOSIS. THE DEVICE WAS NOT USED TO TREAT A CHRONIC TOTAL OCCLUSION. A 6F NON-CORDIS SHEATH WAS INSERTED. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE SDS THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE TRACKING THE SDS TOWARDS THE LESION. AFTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262857 ↗
• MalfunctionDec 23, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, AN 8 X 40 SMART CONTROL ILIAC STENT WAS INSERTED AND DELIVERED TO THE LESION PRE-DILATION AND GOT STUCK ON THE CALCIFIED REGION BEFORE THE PHYSICIAN PUSHED IT WITH FORCE. THERE WAS NO REPORTED PATIENT INJURY. THE STENT¿S EDGE STARTED TO DEPLOY AFTER THE OUTER SHAFT WAS WITHDRAWN. THE LESION USED WAS THE EXTERNAL ILIAC ARTERY AND IT WAS FOR AN ENDOVASCULAR THERAPY CASE. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME SIZED SMART STENT. THE DEVICE WAS BROUGHT AT THE PROCEDURE DATE. THE DEVICE WAS STORED, HANDLED AND PREPPED AS PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED ON THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS NO DAMAGE NOTED ON THE PACKAGING OF THE DEVICE. THERE WERE NO KINKS OR DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. OTHER PRODUCTS USED WITH THE DEVICE DID NOT KINK OR BEND AT ANY TIME. NO OTHER PART OF THE DEVICE WAS KINKED (E.G. OUTER SHEATH, GUIDEWIRE LUMEN ¿ INNER SHAFT). THE STENT DELIVERY SYSTEM DID NOT PASS ANY ACUTE BENDS. THERE WAS LITTLE TORTUOSITY NOTED. THERE WAS 75% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511695 ↗
• InjuryApr 23, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE SMART CONTROL 8X40 STENT WAS BEING DEPLOYED INTO THE AXILLARY VEIN FOR STENOSIS. HOWEVER, UPON DEPLOYMENT THE STENT JUMPED FORWARD BEYOND THE STENOSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541069 ↗
• MalfunctionJun 29, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE SMART CONTROL STENT DELIVERY SYSTEM (SDS), ILIAC 8X40 DISTAL TIP OF THE GUIDEWIRE LUMEN WAS WIDER AND COULD NOT INSERT INTO A SHEATH INTRODUCER. THEREFORE THE SDS WAS REPLACED WITH A NEW SAME SIZE SMART CONTROL STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. A GUIDEWIRE CROSSED THE LESION AND THERE WAS ATTEMPTED TO INSERT A SMART CONTROL STENT. THE TARGET LESION WAS THE SUBCLAVIAN ARTERY. THE PATIENT'S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE WAS INSPECTED PRIOR TO USE AND ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. PHYSICIANS ARE REQUESTING URGENT ANALYSIS RESULTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6678730 ↗
• MalfunctionFeb 3, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE SMART CONTROL STENT DISTAL TIP WAS FRAYED. THEREFORE, THE STENT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A CONTRALATERAL APPROACH WAS ATTEMPTED WITH THE SMART CONTROL STENT BUT ITS TIP GOT STUCK AND FOUND THAT THE TIP WAS FRAYED. THE TARGET LESION WAS THE ILIAC ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301300 ↗
• MalfunctionNov 8, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A SMART CONTROL STENT COULD NOT CROSS THE LESION. A NON CORDIS BALLOON WAS USED TO WIDEN THE LESION, HOWEVER THE STENT STILL COULD NOT CROSS THE LESION. THE PHYSICIAN NOTICED THAT THE STENT WAS SLIGHTLY EXPOSED BETWEEN THE INNER AND THE OUTER SHAFTS. ANOTHER SMART CONTROL STENT WAS USED TO REPLACE THE FIRST ONE AND THE NEW STENT COULD NOT CROSS THE LESION AS WELL. NONE OF THE STENTS WERE DEPLOYED OR PLACED IN THE PATIENT DURING THIS PROCEDURE AND THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. A BILATERAL APPROACH WAS MADE AND A NON CORDIS BALLOON CATHETER WAS USED TO PERFORM PRE- DILATATION. THE TARGET LESION WAS THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCTS WERE CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6087681 ↗

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