Cordis S.M.A.R.T. Control Vascular Stent System C07080MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032023877), received between Oct 1, 2018 and Aug 19, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 7 X 80 SMART CONTROL ILIAC SELF-EXPANDING STENT (SES) WAS ATTEMPTED TO BE DELIVERED TO THE LESION, HOWEVER, IT WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN NOTED THAT THE DISTAL TIP WAS FRAYED. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER DIFFERENT SIZED SMART CONTROL SELF-EXPANDING STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. AN UNKNOWN GUIDEWIRE CROSSED THE LESION AND A PRE-DILATION WAS PERFORMED. THE INTENDED TREATMENT SITE WAS THE ILIAC ARTERY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THERE WAS NOTHING UNUSUAL NOR DAMAGES NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. EXCESSIVE FORCED WAS NOT USED WHEN THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426634 ↗
• MalfunctionOct 1, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING USE, IT WAS REPORTED THAT THE STENT OF THE SMART CONTROL STENT DELIVERY SYSTEM WAS INACCURATELY DEPLOYED AS THE IMPLANTED STENT SEEMED TO BE EXTENDED NEARLY 1 CM IN THE BIFURCATION. THERE WAS NO PATIENT INJURY. THE LESION WAS BETWEEN THE ILIAC ARTERY AND THE SUPERFICIAL FEMORAL ARTERY. A CONTRALATERAL CROSS-OVER APPROACH WAS MADE WITH A COMPETITOR'S 6F GUIDING SHEATH. A COMPETITOR'S GUIDEWIRE CROSSED THE LESION AND A COMPETITOR'S BALLOON CATHETER WAS INSERTED AND INFLATED FOR PRE-DILATION. A SMART STENT (10*40-80) WAS IMPLANTED WITHOUT ANY ISSUES. A SABER BALLOON CATHETER WAS INFLATED FOR A POST DILATION AND ADVANCED TOWARDS THE SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO). A COMPETITOR'S UNKNOWN CATHETER AND A COMPETITOR'S GUIDEWIRE CROSSED THE LESION. A COMPETITOR'S BALLOON CATHETER AND ANOTHER COMPETITOR'S BALLOON CATHETER WERE INSERTED AND INFLATED FOR PRE-DILATION. A SMART STENT (6*120-150) WAS IMPLANTED AT THE DISTAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY. THEN A SMART CONTROL STENT COULD NOT BE DEPLOYED AT THE PROXIMAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN TURNED ITS DIAL UNTIL IT STOPPED TO DEPLOY 4CM OF THE STENT AND ATTEMPTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923250 ↗

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