Cordis S.M.A.R.T. Control Vascular Stent System C08100SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032024256), received between Dec 30, 2016 and Mar 2, 2023 — classified as 2 deaths, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY GORE JAPAN, A PATIENT EXPIRED AFTER AN ON-SITE OPERATION. AN 8MM X 100MM SMART STENT (SES) WAS USED TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. POST-DILATATION WITH AN UNKNOWN BALLOON WAS DONE, RUPTURING A BLOOD VESSEL AND BLEEDING OCCURRED. THE VESSEL RUPTURE OCCURRED WHILE THE UNKNOWN BALLOON WAS IN THE STENT DURING POST-DILATATION. FOR HEMOSTASIS, NON-CORDIS STENT GRAFTS WERE DEPLOYED. A NON-CORDIS BALLOON EXPANDABLE STENT GRAFT WAS DEPLOYED ON THE CENTRAL SIDE, AND A SECOND NON-CORDIS STENT GRAFT WAS DEPLOYED ON THE PERIPHERAL SIDE. HEMOSTASIS WAS ACHIEVED AND THE PATIENT¿S VITAL SIGNS WERE STABLE, SO THE PROCEDURE WAS TERMINATED. APPROXIMATELY ONE DAY POST PROCEDURE, THE PATIENT HAD A SUDDEN CHANGE IN CONDITION REQUIRING RE-OPERATION. RE-BLEEDING OCCURRED, THE CAUSE OF WHICH WAS A SUSPECTED TYPE 2 ENDOLEAK. TWO UNKNOWN STENT GRAFTS AND THREE UNKNOWN BALLOON DILATATION STENT GRAFTS WERE IMPLANTED FROM THE AORTA TO THE BILATERAL ILIAC ARTERIES USING COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) TECHNIQUE TO OCCLUDE THE LUMBAR ARTERY AND CONTRALATERAL INTERNAL ILIAC ARTERY THAT MAY BE COMMUNICATING NEAR THE BLEEDING SITE. AFTER CONFIRM

  Patient problems: Rupture

  MAUDE report 16471139 ↗
• MalfunctionJan 24, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, AFTER THE SMART CONTROL STENT WAS IMPLANTED; HOWEVER THE DEVICE GOT STUCK DURING THE REMOVAL/WITHDRAWAL. THE PHYSICIAN STRONGLY PULLED AND TRIED TO REMOVE SEVERAL TIMES WITHOUT SUCCESS, THE SMART CONTROL, SHEATH AND GUIDEWIRE WERE REMOVED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A STENT GRAFT CASE. THE LESION WAS THE IN THE RIGHT ILIAC. A NON-CORDIS SHEATH WAS INSERTED THROUGH A DRY NON-CORDIS SHEATH. A .035 NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE STENT WAS USED DUE TO THE DISSECTED LESION. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN PULLED THE WIRE OUT FROM THE DISTAL TIP AND IT CAME OUT/OFF SAFELY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339247 ↗
• InjuryDec 29, 2020Incomplete Coaptation; Incomplete Coaptation

  AS REPORTED, AN 8X100 SMART CONTROL SELF-EXPANDING STENT DELIVERY SYSTEM WAS IMPLANTED TO THE LEFT ILIAC ARTERY; HOWEVER, AN ANGIOGRAPHY DID NOT SHOW BLOOD FLOW AT THE REGION WHERE THE COMPLAINT DEVICE WAS IMPLANTED. THE SMART CONTROL SEEMED TO BE SHRUNK AND THROMBUS GOT STUCK. POST-DILATION WAS PERFORMED SEVERAL TIMES, BUT THE SITUATION DID NOT BECOME BETTER. A NON-CORDIS STENT, WHICH IS LONGER THAN THE COMPLAINT DEVICE, WAS IMPLANTED AND THE BLOOD FLOW WAS OBSERVED, AND THE PROCEDURE WAS COMPLETED. THE LESIONS WERE BOTH IN THE ILIAC ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO). AN APPROACH WAS MADE FROM THE INGUINAL AREA. A NON-CORDIS GUIDEWIRE CROSSED THE LESION AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS USED. A DIFFERENT 8MMX6CM SMART CONTROL STENT WAS IMPLANTED AT THE RIGHT ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11088108 ↗
• MalfunctionAug 17, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A PART OF THE 8 X 100 SMART CONTROL ILIAC SELF-EXPANDING STENT (SES) SYSTEM DID NOT DEPLOY AT ALL. POST DILATION (UNKNOWN BALLOON CATHETER) WAS PERFORMED SEVERAL TIMES, BUT RECOIL OCCURRED. AN INTRAVASCULAR ULTRASOUND (IVUS) SHOWED THAT A PART OF THE STRUT SEEMED TO BE BROKEN. ¿THE STENT WAS IMPLANTED AS IF IT COVERED THE STRUT¿ AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE STENT WAS IMPLANTED AT THE ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT IS IMPLANTED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10416569 ↗
• MalfunctionFeb 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A SMART CONTROL ILIAC (8X100) SELF-EXPANDING STENT (SES) WAS INSERTED AND A FEW CENTIMETERS OF THE DISTAL END RELEASED; HOWEVER, THE REST OF IT COULD NOT BE RELEASED EVEN THOUGH THE LEVER WAS SLID. THE DISTAL END PART GOT SEPARATED AFTER THE SMART CONTROL SES WAS WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE COMMON ILIAC ARTERY WHICH HAD CALCIFICATION. A 7MM UNKNOWN BALLOON CATHETER WAS INFLATED FOR PRE-DILATION. A 14¿ UNKNOWN GUIDEWIRE WAS USED. A NEW STENT WAS IMPLANTED AFTER THE LESION WAS INFLATED WITH A NON-CORDIS BALLOON CATHETER AND GUIDEWIRE (35¿ STIFF). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS THE COMMON ILIAC ARTERY. THERE WAS NOT ANY VESSEL TORTUOSITY. THERE WAS NOT ANY VESSEL ANGULATION. THE DEVICE WAS BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NOT ANY ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361419 ↗
• InjuryDec 21, 2017Detachment Of Device Component; Adverse Event Without Identified Device or Use Problem; Detachment Of Device Component; Adverse Event Without Identified Device or Use Problem

  DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE FOR AN OCCLUSION OF A LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND THE EXTERNAL ILIAC ARTERY, TWO SMART STENTS WERE PLACED (C06100SL AND C08100SL). THE SMART STENT (C06100SL) WAS PLACED INTO THE LEFT SFA, IT WAS CONFIRMED THAT THERE WAS NO DISTAL EMBOLUS TO THE DISTAL SIDE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE TIP OF THE NON-CORDIS SHEATH USED WITH CONTRALATERAL APPROACH WAS WITHDRAWN TO THE RIGHT EXTERNAL ILIAC ARTERY, AND STARTED TREATMENT OF THE LEFT EXTERNAL ILIAC ARTERY. AFTER PRE DILATATION OF THE LESION, THE COMPLAINT SMART STENT (C08100SL) WAS ADVANCED TO THE LESION SO THAT IT COULD OVERLAP WITH A NON-CORDIS STENT WHICH HAS PREVIOUSLY BEEN IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY. THE DISTAL TIP OF THE SMART STENT HIT THE PREVIOUS STENT AND IT WAS DIFFICULT POSITIONING THE SMART STENT. FINALLY THE SMART STENT WAS PLACED OVERLAPPING THE PREVIOUS STENT, AND THE SMART STENT WAS DEPLOYED. THEN ANGIOGRAPHY WAS DONE ONLY IN THE ILIAC ARTERY WITH THE SMART STENT AND THE RIGHT PERIPHERAL VESSEL(S) WERE NOT CHECKED BY THE ANGIOGRAPHY. THE PROCEDURE WAS COMPLETED. APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, TH

  Patient problems: Stenosis

  MAUDE report 7139961 ↗
• DeathDec 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SMART CONTROL, ILIAC 8X100 WAS INSERTED AND DEPLOYED IN THE BIFURCATION OF THE INTERNAL ILIAC ARTERY. WITHIN THREE MINUTES DURING A POST-DILATATION, PERFORATION OCCURRED AND THE PATIENT WAS EXPIRED. AN APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A NON CORDIS BALLOON CATHETER (6.0*40MM) WAS INSERTED BUT COULD NOT CROSS THE LESION. THEREFORE, ANOTHER NON CORDIS BALLOON CATHETER (4.0*40MM) WAS INFLATED AS A PRE-DILATATION. THE TARGET LESION WAS THE COMMON FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS 100% (CTO). THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Perforation of Vessels

  MAUDE report 6216558 ↗

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