Cordis S.M.A.R.T. Control Vascular Stent System C06100SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032023655), received between Aug 31, 2016 and Nov 20, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF THE 6X100 SMART CONTROL ILIAC SELF-EXPANDING STENT DELIVERY SYSTEM (SES) WAS NOTED TO BE SPLIT AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THE PROCEDURE WAS THEREFORE COMPLETED BY USING ANOTHER NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE SMART CONTROL WAS INTENDED TO BE USED DURING AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE ILIAC ARTERY WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS SEVERE VESSEL TORTUOSITY NOTED AND THE PERCENTAGE OF STENOSIS WAS ONE HUNDRED PERCENT. THE VESSEL HAS ACUTE ANGULATION AND WAS SEVERELY CALCIFIED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO ANYTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTION FOR USE. THERE WAS UNUSUAL FORCE USED WHEN THE DEVICE CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED BY THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9351127 ↗
• InjuryDec 21, 2017Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; 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 7140190 ↗
• InjuryOct 17, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, APPROXIMATELY FORTY-ONE MONTHS POST IMPLANTATION OF A SMART (SMART CONTROL, ILIAC 6X100) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT HAD STENOSIS IN THE PROXIMAL PORTION OF THE SMART CONTROL STENT THAT IT WAS CONFIRMED BY ANKLE-BRACHIAL INDEX (ABI) TEST, ULTRASONOGRAM (US), AND COMPUTED TOMOGRAPHY SCAN (CT). THEN, APPROXIMATELY FORTY-FOUR MONTHS POST STENT IMPLANTATION, A BALLOON DILATATION WAS PERFORMED FOR THE STENOSIS. THE NEXT DAY, THE PATIENT RECOVERED AND HEMODIALYSIS TREATMENT WAS GIVEN.

  Patient problems: Reocclusion

  MAUDE report 6955293 ↗
• InjuryOct 5, 2016Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE JAPAN SMART PMS FOR SFA, AFTER AN UNSPECIFIED TIME WHEN A 120 150, SFA - 6X150MM SMART STENT AND A 6X100 SMART CONTROL ILIAC STENT WERE PLACED IN THE MIDDLE PORTION TO THE DISTAL PORTION OF THE FEMORAL ARTERY WITH UNKNOWN STENOSIS OF A (B)(6) MALE PATIENT WITH UNKNOWN MEDICAL HISTORY, THE PERIODIC SURVEY REPORTED THAT THE FOLLOWING ITEMS WERE ENTERED AS "OCCLUSION" ON THE LIST; PATENCY, DUS, THE PROXIMAL PORTION OF STENOSIS PSV, AND THE MAXIMUM PSV OF STENOSIS. THE PATIENT IS NOW UNDER OBSERVATION, AND NO TREATMENT WAS APPLIED." ADDITIONAL INFORMATION WAS RECEIVED THAT DUS MEANS DOPPLER ULTRA SOUND. IT NOT KNOWN WHICH STENT WAS PATENT BUT BOTH STENTS HAD PSV. IT IS UNKNOWN IF THE ORIGINAL LESION WAS CALCIFIED OR THE VESSEL TORTUOUS, IF THE STENTS WERE OVERLAPPING, IF THE STENTS WERE DEPLOYED WITH GOOD WALL APPOSITION AND IF IVUS WAS DONE POST PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Reocclusion

  MAUDE report 6000236 ↗
• InjuryAug 31, 2016Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE (B)(6), AFTER AN UNSPECIFIED TIME WHEN A 120 150, SFA - 6X150MM SMART STENT AND A 6X100 SMART CONTROL ILIAC STENT WERE PLACED IN THE MIDDLE PORTION TO THE DISTAL PORTION OF THE FEMORAL ARTERY WITH UNKNOWN STENOSIS, THE PERIODIC SURVEY REPORTED THAT THE FOLLOWING ITEMS WERE ENTERED AS ¿OCCLUSION¿ ON THE LIST; PATENCY, DUS, THE PROXIMAL PORTION OF STENOSIS PSV, AND THE MAXIMUM PSV OF STENOSIS. THE PATIENT IS NOW UNDER OBSERVATION, AND NO TREATMENT WAS APPLIED.¿

  Patient problems: Reocclusion

  MAUDE report 5919417 ↗

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