Cordis S.M.A.R.T. Control Vascular Stent System C09040SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032024416), received between Jan 11, 2018 and Aug 4, 2023 — classified as 1 death, 3 injuries, 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2023Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration

  AS REPORTED BY THE PHYSICIAN, THE 9X40 SMART CONTROL ILIAC STENT SEEMED TO JUMP FORWARD MORE THAN WAS NORMALLY EXPECTED. THE STENT MIGRATED APPROXIMATELY 3-4 CM. THE STENT WAS LEFT IN PLACE IN THE PATIENT. ADDITIONAL STENTS WERE NOT NEEDED TO COMPLETE THE PROCEDURE; THE SURGEON STOPPED FURTHER INTERVENTIONS AFTER STENT FAILURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FILED AND STORED AS PER LABELING. THE INTENDED PROCEDURE WAS REPORTED TO BE AN ANGIOGRAM, ANGIOPLASTY WITH STENT PLACEMENT. THERE WAS NO SIGNIFICANT CALCIFICATION OR TORTUOSITY NOTED WITH SEVENTY PERCENT (70%) STENOSIS AND THIRTY PERCENT (30%) POST-ANGIOPLASTY. THE AREA WAS PREDILATED PRIOR TO STENT IMPLANTATION USING A NON-CORDIS BALLOON. THE DEVICE WAS HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE TRAY. THE DIAMETER OF THE UNCONSTRAINED STENT WAS SIZED 1-2 MM LARGER THAN THE TARGET AREA. THERE WAS NO RESISTANCE/FRICTION DURING INSERTION OF THE DEVICE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17460785 ↗
• InjuryJul 25, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, AN ATTEMPT WAS MADE TO IMPLANT A 9X40 SMART CONTROL ILIAC STENT AT THE STENOSIS OF THE COMMON ILIAC ARTERY USING AN IPSILATERAL RETROGRADE APPROACH; HOWEVER, THE STENT JUMPED AND MOVED CENTRAL SIDE FROM THE DESIRED LOCATION. THE COMPLAINT DEVICE DID NOT COVER THE LESION; THEREFORE, ADDITIONAL STENT(S) WERE ADDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE ILIAC ARTERY DILATATION. THERE WAS MODERATE LESION CALCIFICATION AND TORTUOSITY WITH SEVENTY-FIVE PER CENT (75%) STENOSIS. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU); THERE WERE NO DIFFICULTIES EXPERIENCED IN PREPPING THE DEVICE. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS NOT CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. NOTHING UNUSUAL WAS NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE TRAY. THE DIAMETER OF THE UNCONSTRAINED STENT WAS SIZED 1-2 MM LARGER THAN THE TARGET AREA. THERE WAS NO RESISTANCE/FRICTION DURING INSERTION OF THE DEVICE. THE STENT DELIVERY SYSTEM DID NOT PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17387978 ↗
• DeathFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 9 X 40 SMART CONTROL ILIAC SELF-EXPANDING STENT (SES) WAS IMPLANTED BETWEEN THE COMMON ILIAC ARTERY AND THE LEFT EXTERNAL ILIAC ARTERY. HOWEVER, SEVEN DAYS POST IMPLANTATION; THE PATIENT SUFFERED FROM ACUTE OBSTRUCTION. THE FOLLOWING DAY PATIENT EXPIRED. THE PATIENT EXPIRED APPROXIMATELY SEVEN DAYS POST PROCEDURE. THE LESION HAD SEVERE CALCIFICATION AND STENOSIS. THE BIFURCATING LEFT COMMON ILIAC ARTERY WAS NOT SEVERELY CALCIFIED, MODERATELY TORTUOUS, 70% STENOSED, AND NOT SEVERELY ANGLED. THE LEFT EXTERNAL ILIAC WAS NOT SEVERELY CALCIFIED, HAD MILD TORTUOSITY, 70% STENOSED, AND NOT SEVERELY ANGLED. AN IPSILATERAL ANTEGRADE APPROACH WAS MADE. THE LEFT FEMORAL ARTERY WAS PUNCTURED FOR TREATMENT FOR BOTH LESIONS BUT THERE WERE NO OCCLUSIONS OF THE LEFT FEMORAL ARTERY. A GUIDING NON-CORDIS CATHETER WAS INSERTED INTO THE PATIENT. THE RIGHT SUPERFICIAL FEMORAL ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO) WAS TREATED. NO FINDINGS WERE CONFIRMED BY AN ANGIOGRAPHY. THE TREATMENT WAS DONE SAME DAY. THE LEFT SUPERFICIAL FEMORAL ARTERY WAS ALSO TREATED. A NON-CORDIS STENT WAS IMPLANTED AT THE STASIS REGION. THE SES WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR US

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11341852 ↗
• MalfunctionJan 13, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, A 9MM X 40MM SMART CONTROL SELF-EXPANDING STENT WAS IMPLANTED IN THE COMMON ILIAC ARTERY (CIA) AND AN 8MM X 4CM UNKNOWN BALLOON CATHETER PERFORMED A POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). AFTER THAT, ANGIOGRAPHY REVEALED DISSOCIATION IN THE EXTERNAL ILIAC ARTERY. THEREFORE, AN 8MM X 100MM SMART CONTROL SELF-EXPANDING STENT WAS ATTEMPTED TO BE IMPLANTED AT THE DISSOCIATION PART. HOWEVER, THE UNKNOWN SHEATH CAME OUT FROM THE PATIENT BODY FROM THE FEMORAL ARTERY. SO, THE 8MM X 100MM SMART CONTROL STENT COULD NOT BE INSERTED FROM THE FEMORAL ARTERY. IT WAS ATTEMPTED TO BE INSERTED FROM THE LEFT BRACHIAL; SO, THE SHEATH WAS CHANGED TO ANOTHER 6F NON-CORDIS SHEATH. HOWEVER, THE SMART CONTROL STENT INTERFERED; AND IT WAS JUDGED THAT THE INSERTION FROM THE BRACHIAL WAS IMPOSSIBLE. A 6F 11CM UNKNOWN SHEATH WAS THEN INSERTED IN THE RIGHT FEMORAL ARTERY. DURING DEPLOYMENT OF THE 8MM X 100MM SMART CONTROL STENT, THE DOCTOR CONTROLLED THE POSITION BECAUSE THE PROXY SIDE WAS CLOSE TO THE PUNCTURE SITE. IT SEEMS THAT THE STENT WAS FOUND TO BE OUT OF THE BLOOD VESSEL ON THE WAY. THE DOCTOR TRIED TO PUT BACK THE STENT INTO THE VESSEL, BUT IT COULD NOT. THE DOCTOR DECIDED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164137 ↗
• InjuryJun 19, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE SMART CONTROL STENT WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU), HOWEVER, IT JUMPED ABOUT 2-CENTIMETERS (CM) AND COULD NOT COVER THE LESION COMPLETELY. THE SMART CONTROL WAS THEREFORE REPLACED WITH A NEW NON-CORDIS STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT COMMON ILIAC ARTERY AND THE POSTERIOR TIBIAL ARTERY. THE VESSEL LEVEL OF CALCIFICATION IS MILD. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS NONE. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO EXCESS FORCE USED DURING INSERTION. THERE WAS NO DIFFICULTY OR RESISTANCE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO EXCESSIVE TORQUE USED DURING ADVANCEM

  Patient problems: No Code Available

  MAUDE report 8711623 ↗
• InjuryJan 11, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  AS REPORTED A SMART CONTROL, ILIAC 9 X 40 STENT WAS DEPLOYED IN A FISTULA AND UPON DEPLOYMENT, IT APPEARS TO HAVE FOLDED OVER ON TOP OF ITSELF. PHYSICIAN WAS REQUIRED TO PLACE AN ADDITIONAL STENT ACROSS IT TO SUCCESSFULLY COMPLETE THE CASE. CATHETER WAS NOT SAVED FOR ANALYSIS. THERE WAS NO PATIENT INJURY REPORTED. 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 PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. NOTHING UNUSUAL WAS NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE IFU INSTRUCTS THE USER TO HOLD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT AND THIS WAS DONE. THERE WAS NO UNUSUAL FORCE APPLIED DURING DEPLOYMENT OF THE STENT. NONE OF THE STENT HAD BEEN PRE-MATURELY DEPLOYED. THE TANTALUM MARKERS W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7182660 ↗

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