Cordis S.M.A.R.T. Control Vascular Stent System C08030SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032024072), received between Jan 30, 2017 and Apr 23, 2022 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 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 14191032 ↗
• InjurySep 3, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A NON-CORDIS GUIDEWIRE CROSSED THE LESION AND A SMART CONTROL, ILIAC 8 X 30 WAS INSERTED. IT WAS DELIVERED TO THE LESION, HOWEVER, IT ADVANCED TOO FAR AND COULD NOT COVER THE LESION. THEREFORE ANOTHER SMART CONTROL STENT (C08040S) WAS USED ADDITIONALLY. A NON CORDIS BALLOON CATHETER WAS USED. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE LEFT EXTERNAL ILIAC ARTERY. A CONTRALATERAL APPROACH WAS MADE. THE PATIENT¿S INFORMATION, PATIENT¿S VESSEL LEVEL OF TORTUOSITY, CALCIFICATION AND RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. NO DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6840708 ↗
• MalfunctionJan 30, 2017Difficult or Delayed Positioning; Material Frayed; Torn Material; Difficult or Delayed Positioning; Material Frayed; Torn Material

  IT WAS REPORTED THAT DURING THE PROCEDURE, A NON-CORDIS GUIDEWIRE CROSSED THE LESION AND A SLEEK BALLOON CATHETER WAS INFLATED. A  SMART CONTROL STENT WAS DELIVERED TO THE LESION BUT THE STENT WAS UNABLE TO BE DEPLOYED. THE GUIDEWIRE IN USE WAS EXCHANGED TO ANOTHER NON-CORDIS GUIDEWIRE AND THE STENT WAS ATTEMPTED TO BE DEPLOYED ONCE MORE. HOWEVER, THE SMART CONTROL STENT GOT STUCK WITH THE GUIDEWIRE AND BOTH DEVICES WERE REMOVED. AFTER THE REMOVAL, IT WAS CONFIRMED THAT THE DISTAL TIP OF THE SMART CONTROL WAS FRAYED. THE STENT WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. ADDITIONAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287375 ↗

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