Cordis S.M.A.R.T. Vascular Stent System C07120MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032063422), received between Aug 21, 2017 and May 9, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THERE WAS RESISTANCE WITH A 7X120MM SMART SELF-EXPANDING STENT (SES) DELIVERY SYSTEM SO IT COULD NOT CROSS. THE SMART SES WAS REMOVED AND CHECKED; THE DISTAL END OF THE TIP GOT FRAYED. THEREFORE, IT WAS REPLACED WITH A NEW UNKNOWN SMART STENT. THERE WAS NO REPORTED PATIENT INJURY. AN UNKNOWN BALLOON CATHETER WAS INFLATED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336553 ↗
• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE SMART PMS FOR SFA 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 7064997 ↗
• InjuryAug 21, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED, THE PATIENT WAS ENROLLED IN A CLINICAL STUDY (B)(6) FOR SFA AND THE CASE NUMBER IS (B)(6). THE PATIENT HAD A 120/150 SMART SFA 7 X 120 STENT SUCCESSFULLY IMPLANTED IN THE MID LEFT FEMORAL ARTERY TARGET LESION WITHOUT ANY ISSUE DURING THE STUDY INDEX PROCEDURE. NO TARGET LESION CHARACTERISTIC INFORMATION WAS AVAILABLE. THREE (3) YEARS SEVEN (7) MONTHS AND THREE (3) DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED IN-STENT-RESTENOSIS (ISR) OF THE PREVIOUSLY IMPLANTED SMART STUDY STENT AND TARGET LESION REVASCULARIZATION (TLR) WAS PERFORMED. THE PATIENT WAS REPORTED TO HAVE RECOVERED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PERCENT OF IN STENT RESTENOSIS REPORTED WAS NOT KNOWN. NO ADDITIONAL TARGET LESION CHARACTERISTIC INFORMATION WAS AVAILABLE. THERE WAS NO SPECIFIC INFORMATION AVAILABLE AS TO THE INTERVENTION PERFORMED TO TREAT THE ISR. IT WAS UNKNOWN WHAT THE PATIENT¿S MEDICAL REGIMEN POST-PROCEDURE WAS OR IF THE PATIENT WAS COMPLIANT WITH THE MEDICAL REGIMEN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Reocclusion

  MAUDE report 6808267 ↗