Cordis S.M.A.R.T. Control Vascular Stent System C08060SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032024157), received between Sep 27, 2016 and Apr 23, 2022 — classified as 1 death, 1 injury, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE FIRST SMART CONTROL WAS IMPLANTED; HOWEVER, THE STENT ACCIDENTLY POPPED OUT AND IMPLANTED IN THE AORTA. ITS PROXIMAL EDGE BARELY HUNG OVER THE ENTRANCE AREA. A SECOND SMART CONTROL STENT WAS IMPLANTED AND ATTEMPTED TO STABILIZE IN THE SUBCLAVIAN ARTERY; HOWEVER, IT POPPED OUT AS WELL AND FELL TO THE VICINITY OF THE L2 OF THE AORTA WITH THE 8X60 STENT OVERLAPPING THE 8X30 STENT. THE AORTA DIAMETER WAS NARROW AND WAS TRAPPED IN CALCIFICATION AND WAS IMPLANTED ALONG THE AORTA. THE LESION WAS THE SUBCLAVIAN ARTERY WITH STENOSIS. A SMART 9X40 WERE IMPLANTED IN SUBCLAVIAN ARTERY LESION. A NON-CORDIS 5X40 BALLOON CATHETER WAS INFLATED AS POST-DILATION AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. A LEFT UPPER EXTREMITY APPROACH WAS MADE WITH A NON-CORDIS GUIDING CATHETER AND A NON-CORDIS WIRE CROSSED THE LESION. A SABER OTW (3-40) WAS INFLATED AS PRE-DILATION. THERE WAS AN ATTEMPT TO RETRIEVE THE PATIENT DUE TO THE PATIENT HAVING TEMPORARY LEG AND ABDOMINAL PAIN, BUT THE PATIENTS SYMPTOMS CALMED DOWN AND IT WAS DECIDED TO FOLLOW UP. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191034 ↗
• MalfunctionJun 26, 2018Material Frayed; Difficult To Position; Material Frayed; Difficult To Position

  DURING USE, IT WAS REPORTED THAT SMART CONTROL STENT DID NOT CROSS THE LESION AND UPON REMOVING, THE DISTAL TIP AND THE OUTER SHEATH WERE FRAYED. THERE WERE NO PATIENT INJURY. THE SMART CONTROL WAS REPLACE WITH A NEW SMART CONTROL. THE STENT WAS IMPLANTED AND POST DILATATION WAS PERFORMED TO COMPLETE THE PROCEDURE. THE LESION WAS THE ILIAC ARTERY. A CONTRALATERAL APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A SUPPORT 6F COMPETITOR'S SHEATHLESS CATHETER AND IT MADE A CROSS-OVER. A 0.35 COMPETITOR'S GUIDEWIRE CROSSED THE LESION AND AN IVUS CONFIRMED THE LESION. A PRE DILATATION WAS MADE WITH AN UNKNOWN BALLOON CATHETER. THEN A SMART CONTROL STENT WAS INSERTED. HOWEVER IT COULD NOT CROSS THE LESION. THE GUIDEWIRE WAS EXCHANGED TO ANOTHER GUIDEWIRE (035 STIFF) AND ATTEMPTED TO DELIVER THE STENT SEVERAL TIMES, BUT IT COULD NOT BE DELIVERED. THE STENT WAS REMOVED FROM THE PATIENT AND IT WAS CONFIRMED THAT THE DISTAL TIP AND THE OUTER SHEATH WERE FRAYED. THE DEVICE WILL NOT BE RETURNED AS THE DEVICE HAS BEEN DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638488 ↗
• MalfunctionDec 5, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, WHEN A SMART CONTROL STENT WAS ATTEMPTED TO BE DELIVERED, HOWEVER IT WAS CAUGHT BY A PREVIOUS SMART STENT IN THE COMMON ILIAC ARTERY AND WAS UNABLE TO PASS THROUGH AFTER SEVERAL ATTEMPTS. SINCE A GAP WAS CONFIRMED BETWEEN THE INNER AND OUTER SHAFT, IT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A POWERFLEX BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS THE EXTERNAL ILIAC ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. INITIALLY, A BRITE TIP SHEATH WAS UNABLE TO BE INSERTED AND THE DISTAL END GOT FRAYED. THE BRITE TIP SHEATH WAS REPLACED WITH A NEW SHEATH INTRODUCER. AFTER THE ANGIOGRAPHY, THE SHEATH WAS REPLACED WITH A NON-CORDIS GUIDE CATHETER AND WAS DELIVERED TO THE LESION USING A CONTRALATERAL APPROACH. A POWERFLEX BALLOON WAS THEN INFLATED FOR PRE-DILATATION. THE PRODUCTS WERE CLINICALLY USED AND THEY WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084196 ↗
• MalfunctionSep 11, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THERE WAS AN ATTEMPTED TO DEPLOY A SMART CONTROL STENT IN THE TARGET LESION. HOWEVER THE DISTAL END OF THE STENT WAS CONFIRMED TO BE PREMATURELY DEPLOYED. THE SMART CONTROL WAS REPLACED WITH A NEW UNKNOWN STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE COMMON ILIAC ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE TEMPERATURE WAS EXPOSURE INDICATOR ON THE POUCH CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS INSPECTED, PREPPED, STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NOTHING UNUSUAL OR DAMAGES NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856167 ↗
• DeathSep 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS ENROLLED IN A CLINICAL STUDY (B)(6) AND THE CASE NUMBER IS (B)(4). THE PATIENT HAD A SMART CONTROL ILIAC 8 X 60 STENT IMPLANTED IN THE TARGET LESION DURING THE INDEX PROCEDURE WITH NO REPORTED ISSUE. THE TARGET LESION WAS THE MIDDLE PORTION OF THE LEFT FEMORAL ARTERY. THE LESION WAS REPORTED TO BE: A 60.9% STENOSIS, MILDLY CALCIFIED AND MILDLY TORTUOUS. APPROXIMATELY THIRTY-FOUR MONTHS AFTER THE STUDY INDEX PROCEDURE, THE PATIENT EXPIRED. THE DETAILS OF THE CAUSE OF DEATH WERE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS REPORTED TO BE UNKNOWN: WAS AN AUTOPSY PERFORMED; IF NO AUTOPSY PERFORMED, CAN YOU PLEASE PROVIDE A CAUSE OF DEATH; WHAT IS THE PATIENT'S MEDICAL HISTORY; WHAT WAS THE PATIENT'S MEDICAL REGIMEN POST-PROCEDURE; WAS THE PATIENT COMPLIANT WITH THE MEDICAL REGIMEN; WAS THE REPORTED AE REPORTED TO BE RELATED OR UNRELATED TO THE STUDY DEVICE BY THE STUDY INVESTIGATOR/PHYSICIAN; WAS THE REPORTED AE REPORTED TO BE RELATED OR UNRELATED TO THE STUDY INDEX PROCEDURE DEVICE BY THE STUDY INVESTIGATOR/PHYSICIAN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 5981978 ↗

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