Cordis S.M.A.R.T. Control Vascular Stent System C08060MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032024133), received between Oct 10, 2016 and Dec 6, 2017 — classified as 4 injuries, 3 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, FOUR YEARS POST IMPLANTATION OF A THREE SMART (SMART 120 150, SFA - 6 X 150 MM / SMART CONTROL, ILIAC 8 X 60 ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT WAS HOSPITALIZED DUE TO IN-STENT RESTENOSIS AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR TARGET LESION REVASCULARIZATION. THE TOTAL LENGTH OF THE STENTED SEGMENT IS 360 MM (150+150+60). THERE WERE THREE (3) STENTS PLACED. THE RESTENOSIS WAS LOCATED INSIDE AND ON THE EDGE OF THE STENT. A NON-CORDIS STENT GRAFT WAS IMPLANTED. THE TARGET LESION WAS IN-STENTS AND THE EDGE OF THE STENTS. THE PATIENT RECOVERED. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

  Patient problems: Reocclusion; Vascular System (Circulation), Impaired

  MAUDE report 7088455 ↗
• InjuryOct 3, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED, THE PATIENT WAS ENROLLED IN A CLINICAL STUDY, (B)(6). THE PATIENT HAD TWO (2 EACH) SMART CONTROL STENTS IMPLANTED SUCCESSFULLY DURING THE STUDY INDEX PROCEDURE WITH NO REPORTED ISSUE: A SMART CONTROL ILIAC 8 X 60, AND A SMART CONTROL ILIAC 10 X 40. THE TARGET LESION WAS THE DISTAL PORTION OF THE LEFT FEMORAL ARTERY (LFA). NO TARGET LESION CHARACTERISTIC INFORMATION INCLUDING PERCENT STENOSIS WAS PROVIDED. THREE YEARS ELEVEN MONTHS AND FOURTEEN DAYS AFTER THE INDEX PROCEDURE, THE PATIENT VISITED THE HOSPITAL FOR A PERIODIC EXAMINATION AND ECHOGRAPHY WAS DONE TO THE LEFT SUPERFICIAL FEMORAL ARTERY. THEN A RESTENOSIS IN THE STENT(S) WAS CONFIRMED. SINCE THE PATIENT HAVE A LIGHT SYMPTOM, NO TREATMENT WAS APPLIED AND WILL BE FOLLOWED UP. THE PATIENT WAS NOT RECOVERED. THE RELEVANCY WITH THE PRODUCT: NONE (PRIMARY DISEASE). THE RELEVANCY WITH THE PROCEDURE: NONE (PRIMARY DISEASE). ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE TARGET LESION FOR THE PATIENT¿S INDEX PROCEDURE WAS THE DISTAL PORTION OF THE LEFT FEMORAL ARTERY. IT WAS UNKNOWN IF THE TWO STENTS THAT WERE IMPLANTED DURING THE INDEX PROCEDURE WERE IMPLANTED IN OVERLAPPING FASHION. THE LIGHT SYMPTOMS THE PATIENT

  Patient problems: Reocclusion

  MAUDE report 6911747 ↗
• MalfunctionMar 24, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE SMART CONTROL ILIAC 8X60ML DISTAL TIP WAS FRAYED. THE STENT WAS REPLACED WITH ANOTHER DEVICE (UNKNOWN) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. AFTER AN UNKNOWN GUIDEWIRE CROSSED THE LESION, A SMART CONTROL WAS ADVANCED TO THE LESION BUT IT COULD NOT ADVANCE. THEREFORE THE STENT WAS REMOVED FROM THE PATIENT¿S BODY AND IT WAS FOUND THAT THE DISTAL TIP WAS FRAYED. THE TARGET LESION WAS UNKNOWN. 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 6432584 ↗
• MalfunctionFeb 6, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE, THE SMART CONTROL 8 X 60 ILIAC STENT WAS PREMATURELY AND PARTIALLY DEPLOYED. THE PRODUCT WAS REPLACED WITH A NEW SMART CONTROL STENT. THE PROCEDURE FINISHED SUCCESSFULLY. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. NO TARGET LESION CHARACTERISTIC INFORMATION WAS AVAILABLE. A CONTRALATERAL APPROACH WAS MADE. AFTER DELIVERY OF THE SMART CONTROL STENT (COMPLAINT PRODUCT), THE DELIVERY SYSTEM WAS REMOVED. HOWEVER THE OUTER SHEATH SLID DURING REMOVAL. A NON-CORDIS SHEATH AND NON-CORDIS GUIDEWIRE WERE USED FOR THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6303853 ↗
• InjuryNov 22, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT RESTENOSIS WAS CONFIRMED IN A PATIENT WHO HAD TWO SMART STENTS AND A SMART CONTROL STENT PREVIOUSLY PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. AFTER THE RESTENOSIS WAS CONFIRMED, A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED A MONTH LATER. THE PATIENT RECOVERED. THE TARGET LESION WAS THE PROXIMAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL WAS NOT CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 100%. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: Reocclusion

  MAUDE report 6120065 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IN-STENT RE-STENOSIS WITH TWO SMART STENTS AND A SMART CONTROL STENT. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR THE EDGES OF THE LESION, INSIDE THE IN-STENT RE-STENOSIS, AND WHOLE LESION. THE PATIENT RECOVERED. TWO SMART STENTS AND A SMART CONTROL STENT WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE ON (B)(6) 2013. THREE YEARS LATER (B)(6) 2016, INTERMITTENT CLAUDICATION WAS CONFIRMED ON THE PATIENT. THE PATIENT HAD AN ANGIOGRAPHY EXAMINATION ON (B)(6) 2016, AND PPI WAS PERFORMED. THE RATE OF ABI BEFORE PPI WAS 0.96 IN THE RIGHT AND 0.48 IN THE LEFT. THE RATE OF STENOSIS BEFORE PPI WAS 50 TO 99 % OF STENOSIS. THE TARGET LESION WAS THE DISTAL, MIDDLE, AND PROXIMAL PORTIONS OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100%. THIS IS A CASE FROM (B)(6) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(4).

  Patient problems: Reocclusion

  MAUDE report 6087728 ↗
• MalfunctionOct 10, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING A STENTING PROCEDURE TO THE EXTERNAL ILIAC ARTERY, IT WAS REPORTED THAT WHEN THE SMART CONTROL STENT DELIVERY SYSTEM (SDS) WAS ADVANCING THROUGH THE COMMON ILIAC ARTERY, THE OUTER SHEATH SLID AND THE STENT WAS PARTIALLY/PREMATURELY DEPLOYED. THEREFORE IT WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW SMART CONTROL WITH A SUPPORT WIRE. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. A CONTRALATERAL APPROACH WAS MADE. A DESTINATION SHEATH WAS USED AND A RADIFORCUS GUIDE WIRE. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6013777 ↗

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