Cordis S.M.A.R.T. Vascular Stent System C08120MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032063392), received between Nov 29, 2017 and Feb 21, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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.

• MalfunctionFeb 21, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 8X120MM SMART STENT COULD NOT CROSS THE LESION. SO, IT WAS REMOVED FROM THE PATIENT. THERE WAS A GAP BETWEEN THE DISTAL TIP AND THE OUTER SHEATH. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. A NON-CORDIS BALLOON CATHETER WAS INFLATED AS A PRE-DILATION. AFTER THE SMART STENT FAILED TO CROSS THE LESION AND REMOVED FROM THE PATIENT, THE BALLOON CATHETER WAS INFLATED AND TRIED AGAIN. HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN TRIED TO CROSS THE STENT AFTER ANOTHER NON-CORDIS BALLOON CATHETER WAS INFLATED BUT THE SAME ISSUE OCCURRED AGAIN. THE STENT WAS REPLACED WITH A NEW NON-CORDIS STENT AND IMPLANTED DUE TO THE SMART STENT HAVING A GAP BETWEEN THE DISTAL TIP AND THE OUTER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358658 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY THIRTY-NINE MONTHS POST IMPLANTATION OF THREE SMART (SMART 120 150, SFA - 7X120MM, 8X120MM, SMART CONTROL, ILIAC 8X100ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT HAD INTERMITTENT CLAUDICATION APPEARED AND ALSO A RIGHT SUPERFICIAL FEMORAL ARTERY OCCLUSION AND STENOSIS OF THE RIGHT COMMON FEMORAL ARTERY ORIGIN WAS CONFIRMED BY DOPPLER ULTRASOUND (DUS). A TREATMENT PLAN WAS GOING TO BE DETERMINED THE NEXT TIME THE PATIENT VISITS THE HOSPITAL. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

  Patient problems: Claudication; Occlusion; Stenosis

  MAUDE report 7067898 ↗