Cordis S.M.A.R.T. Vascular Stent System C08150MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032063415), received between Jan 6, 2017 and Mar 15, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE DISTAL TIP OF AN 8MM X 150MM SMART SES (SELF-EXPANDING STENT) DELIVERY SYSTEM WAS INSERTED AND GOT FRAYED WHEN DELIVERED TO THE LESION. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER SMART STENT. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS INFLATED WITH BALLOON CATHETERS. THE TARGET LESION WAS THE ILIAC. ACCESS VESSEL CHARACTERISTICS INCLUDED MILD CALCIFICATION AND TORTUOSITY IN ADDITION TO NINETY PERCENT STENOSIS. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS NOT CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH WHEN IT WAS REMOVED FROM THE TRAY. THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE STOPCOCK OR FLUSHING THE SDS. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THE DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE SDS DID NOT PASS THROUGH A PREVIOUSLY PLACED STENT. THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546672 ↗
• MalfunctionFeb 9, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE OUTER SHEATH OF AN 8MM X 150MM 120CM S.M.A.R.T. SFA SELF-EXPANDING STENT (SES) WAS UNABLE TO MOVE. AS A RESULT, THE S.M.A.R.T. STENT WAS UNABLE TO BE DEPLOYED. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AND THE DEVICE WILL BE RETURNED FOR EVALUATION. PER VISUAL ANALYSIS, THE STENT OF THE UNIT WAS OBSERVED DEPLOYED APPROXIMATELY 5 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498478 ↗
• MalfunctionMay 10, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 8MM X 150MM X 120CM SUPERFICIAL FEMORAL ARTERY (SFA) SMART SELF-EXPANDING STENT (SES) SYSTEM WAS BEING DELIVERED BUT APPROXIMATE 2 STRUTS FROM THE DISTAL END, THE STENT BEGAN TO DEPLOY ALREADY, AND IT WAS NOT ABLE TO OVERLAP THE FORMER SMART STENT (7.0MM*150MM). THE SMART STENT 8MM X 150MM X 120CM WAS REPLACED WITH ANOTHER SMART STENT (8.0MM*120MM) AND IT WAS IMPLANTED. POST-DILATION WAS DONE WITH A SABER RAPID EXCHANGE (RX) BALLOON CATHETER (5.0MM*250MM) AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO). AN APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A CROSS-OVER ANTEGRADE APPROACH WAS MADE WITH A GUIDING SHEATH (6F NON-CORDIS). A GUIDEWIRE (UNKNOWN) CROSSED THE LESION. PRE-DILATION WAS DONE WITH TWO SABER RX BALLOON CATHETERS (4.0MM*250MM AND 5.0MM*250MM). THE SMART STENT (7.0MM*150MM) WAS IMPLANTED AT THE DISTAL SUPERFICIAL FEMORAL ARTERY. THE SMART STENT (8.0MM*120MM) WAS USED FOR IMPLANTATION AT THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802412 ↗
• MalfunctionApr 1, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AFTER A WIRE CROSSED THE LESION, THE 8MM X 150MM SMART CONTROL SELF EXPANDING STENT (SES) WAS INSERTED HOWEVER, IT WAS DIFFICULT TO DELIVER TO THE LESION. THEREFORE, IT WAS REMOVED FROM THE PATIENT¿S BODY AND THE PHYSICIAN FOUND OUT THAT THE DISTAL END OF THE TIP WAS FRAYED. THE DEVICE WAS REPLACED WITH A NEW SMART STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913592 ↗
• MalfunctionApr 21, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE SMART STENT 120 150, SFA - 8X150MM WAS DIFFICULT TO DEPLOY. THE DEVICE WAS EVALUATE BY FAL AND IT WAS CONFIRMED THAT THE SMART STENT WAS RECEIVED PARTIALLY DEPLOYED. THEREFORE THE DEVICE WAS REPLACED WITH A NEW SMART STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. A 6F NON CORDIS GUIDING SHEATH AND A 300CM NON CORDIS GUIDEWIRE CROSSED THE LESION AND A SMART STENT WAS DELIVERED. THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, HOWEVER, THE STENT DID NOT DEPLOY EVEN THOUGH THE OUTER SHEATH WAS RETRACTED AND THE VALVE WAS OPEN. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE RETURNING DEVICE IS HALFWAY DEPLOYED DUE TO THE OTHER PHYSICIAN WHO ATTEMPTED TO DEPLOY THE STENT OUTSIDE THE PATIENT. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WAS NOTHING UNUSUAL OR ANY DAMAGES NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6511026 ↗
• MalfunctionJan 6, 2017Difficult or Delayed Positioning; Difficult To Position; Difficult or Delayed Positioning; Difficult To Position

  IT WAS REPORTED THAT DURING THE PROCEDURE, A GUIDEWIRE AND A NON-CORDIS BALLOON CATHETER WERE INFLATED IN THE LESION AS A PRE-DILATION. A SMART STENT WAS THEN INSERTED BUT WAS UNABLE TO CROSS THE LESION. THE BALLOON CATHETER WAS INFLATED AGAIN AND THE STENT WAS ATTEMPTED TO BE DELIVERED HOWEVER IT WAS STILL UNABLE TO CROSS AND WAS REMOVED FROM THE PATIENT. ONCE IT WAS REMOVED, THE DISTAL TIP OF THE STENT WAS CONFIRMED TO BE SLIGHTLY EXPOSED. THERE WAS ALSO A GAP BETWEEN THE INNER AND OUTER SHAFT. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT STENT DEPLOYMENT. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE PATIENT¿S VESSEL WAS TORTUOUS AND CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6230407 ↗