Cordis S.M.A.R.T. Control Vascular Stent System C07060SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032023853), received between Jun 29, 2018 and Jan 17, 2020 — classified as 1 injury, 1 malfunction.

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

• InjuryJan 17, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 7 X 60 SMART CONTROL ILIAC STENT WAS USED HOWEVER, IT WAS IMPLANTED 2CM AWAY FROM THE TARGET LESION TO THE CENTRAL SIDE. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS BETWEEN THE LEFT COMMON ILIAC ARTERY (CIA) AND THE EXTERNAL ILIAC ARTERY (EIA) WITH STENOSIS. THE LESION WAS 5CM. A CONTRALATERAL APPROACHED WAS MADE. THE DISTAL SIDE OF THE STENT WAS TO BE PLACED JUST BELOW THE AORTIC BIFURCATION HOWEVER, THE STENT SPANNED, AND THE AORTIC BIFURCATION WAS PLACED IN THE RIGHT CIA CENTER ON THE SAME SIDE. IT WAS CHECKED WITH CONTRAST THAT NO BLOOD FLOW OBSTRUCTION WAS CAUSED BY THE STENT. FOLLOW-UP WAS DONE AS IT WAS. WHEN THE STENT WAS DEPLOYED, THE DIAL WAS TURNED COMPLETELY HOWEVER, THE OUTER SHEATH DID NOT MOVE AT ALL. THE DOCTOR FELT SOMETHING ABNORMAL AND TRIED TO REMOVE THE DELIVERY SYSTEM HOWEVER, THE STENT BEGAN TO DEPLOY AS IT BEGAN TO RETRACT INTO THE NON-CORDIS GUIDING SHEATH. SINCE IT WAS NOT POSSIBLE TO GO BACK AS FAR AS IT HAD BEEN PARTIALLY DEPLOYED THEREFORE, IT WAS IMPLANTED AS IT WAS. THE SMART CONTROL STENT USED WITH A NON-CORDIS GUIDEWIRE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 9602985 ↗
• MalfunctionJun 29, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE, AS THE SMART CONTROL ILIAC 7 X 60 STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARDS THE TARGET LESION, THE OUTER SHAFT MOVED, AND THE STENT WAS SLIGHTLY DEPLOYED. IT IS UNKNOWN IF THE SDS BECAME CAUGHT ON THE LESION CALCIFICATION. THE PRODUCT WAS REMOVED AND REPLACED WITH A 120 CM. SMART 7 MM/ X 6 CM. SDS TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). AN IPSILATERAL APPROACH WAS MADE. AN UNKNOWN GUIDEWIRE WAS USED TO CROSS THE TARGET LESION AND THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ABOUT ONE (1) CM. OF THE STENT WAS NOTED TO HAVE PREMATURELY DEPLOYED. THE SDS WAS NOT ADVANCED THROUGH ANOTHER STENT. THERE WAS SOME TRACKING DIFFICULTY NOTED, AS THE STENT GOT CAUGHT ON THE TARGET LESION DURING ADVANCEMENT. THERE WAS NO ATTEMPT MADE TO INTENTIONALLY DEPLOY THE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY WITH THE OTHER SMART STENT THAT WAS USED. THE TARGET LESION WAS REPORTED TO BE: NOT TORTUOUS, A 90% STENOSIS, AND THE ENTIRE LESION CIRCUMFERENCE WAS CAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651892 ↗

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