Cordis S.M.A.R.T. Control Vascular Stent System C10060SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032024652), received between May 23, 2017 and Jun 23, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, DURING TREATMENT OF A LESION IN THE RIGHT COMMON ILIAC ARTERY, A 10MM X 60MM 80CM S.M.A.R.T. CONTROL ILIAC SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS DELIVERED TO THE AORTA OVER A 135CM NON-CORDIS GUIDEWIRE TO ADJUST THE IMPLANTATION POSITION. DURING THE ADJUSTMENT OF THE IMPLANTATION POSITION, THE INTERVENTIONAL PHYSICIAN WAS DISCUSSING THE IMPLANTATION POSITION WITH ANOTHER PHYSICIAN WHEN THE STENT WAS MISTAKENLY DEPLOYED AND IMPLANTED IN THE ABDOMINAL AORTA, EXTENDING FROM BELOW THE RENAL ARTERY TO JUST ABOVE THE COMMON ILIAC ARTERY (CIA) BIFURCATION. A 6F 21CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) THAT WAS INITIALLY USED FOR THE PROCEDURE WAS REPLACED WITH A 7F 43CM NON-CORDIS CSI AND AN UNKNOWN SNARING DEVICE WAS USED TO PULL THE STENT INTO THE 7F 43CM NON-CORDIS CSI AND REMOVE THE STENT SUCCESSFULLY. AS A RESULT, A NEW 10MM X 60MM 80CM S.M.A.R.T. CONTROL ILIAC SES DELIVERY SYSTEM WAS USED, AND THE STENT WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE AORTA. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE PRIOR TO USE. THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14792777 ↗
• MalfunctionNov 11, 2020Material Frayed; Material Frayed

  RESISTANCE WAS FELT AFTER A 10MM X 60MM X 80CM SMART CONTROL, ILIAC SELF-EXPANDING STENT (SES) SYSTEM WAS INSERTED WHILE ADVANCING TO THE LESION, AND THE TIP (THE DISTAL END) FRAYED. THEREFORE, IT WAS REPLACED WITH A NEW SMART STENT. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. INITIALLY, A .35 UNKNOWN WIRE CROSSED THE LESION AND AN UNKNOWN BALLOON CATHETER WAS INFLATED. THEN THE SMART CONTROL DEVICE WAS INSERTED. THE TEMPERATURE EXPOSURE INDICATOR ON THE PRODUCT POUCH WAS 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. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE ACCESS SITE WAS THE FEMORAL AND THE SITE WAS MODERATELY CALCIFIED. THE RESISTANCE WAS FELT WHILE ADVANCING TO THE TARGET VESSEL. THE 90% OCCLUDED LESION WAS 5CM IN LENGTH WITH MODERATELY CALCIFICATION, AND MODERATE VESSEL TORTUOSITY. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822367 ↗
• MalfunctionMar 24, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AFTER PRE DILATION USING 8MM X 4CM SABER, THE 10 X 60 SMART CONTROL ILIAC SELF-EXPANDING STENT DELIVERY SYSTEM (SES) WAS USED BUT IT DID NOT DEPLOY WHEN THE PHYSICIAN TRIED TO TURN THE TUNING DIAL. ADDITIONAL INFORMATION WAS RECEIVED AND PER VISUAL ANALYSIS, THE STENT OF THE UNIT WAS DEPLOYED APPROXIMATELY 0.6 CM. THEREFORE, IT WAS REPLACED WITH A NEW 10MM 6CM NON- CORDIS STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD NO INFECTIOUS DISEASE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR THERAPY (EVT) CASE AT RIGHT COMMON ILIAC ARTERY. AN IPSILATERAL APPROACH WAS MADE. THE LESION WAS THE COMMON ILIAC ARTERY WHICH HAD STENOSIS. THE TARGET LESION VESSEL WAS 8-9MM DIAMETER AND WAS ABOUT 4 CM LENGTH. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN THE VESSEL DIAMETER. A NON-CORDIS GUIDEWIRE CROSSED AND INTRA VASCULAR ULTRASOUND (IVUS) WAS PERFORMED. THE TARGET LESION HAD 80% STENOSIS, LESI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871670 ↗
• MalfunctionApr 11, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A SMART CONTROL STENT ILIAC 10X60 WAS INSERTED USING A CONTRALATERAL APPROACH, HOWEVER; THERE WAS STRONG RESISTANCE FELT WHEN IT WAS INSERTED INTO THE ENTRY OF THE NON-CORDIS GUIDING SHEATH. THERE WERE NO REPORTED PATIENT INJURIES. THERE WAS DIFFICULTY WHILE IT ADVANCED, SO IT WAS REMOVED FROM THE PATIENT. IT WAS CONFIRMED THAT THE OUTER SHEATH WAS FRAYED. THEREFORE, IT WAS REPLACED WITH A NEW SMART STENT AND THE PROCEDURE WAS COMPLETED. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505040 ↗
• MalfunctionMay 23, 2017Material Frayed; Torn Material; Material Frayed; Torn Material

  AS REPORTED, A NON-CORDIS GUIDE WIRE WAS INSERTED BUT COULD NOT CROSS. A CHEVALIER UNIVERSAL 300 WAS INSERTED BUT ALSO COULD NOT CROSS. A NON-CORDIS GUIDE WIRE SUCCESSFULLY CROSSED THE LESION. A SMART CONTROL, ILIAC 10 X 60 WAS INSERTED IT WAS UNABLE TO CROSS THE LESION. THE DISTAL TIP OF THE SMART CONTROL STENT WAS CONFIRMED TO BE FRAYED. THEREFORE IT WAS REPLACED WITH A NEW STENT SYSTEM. THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCTS WERE CLINICALLY USED AND THEY WILL NOT BE RETURNED FOR ANALYSIS. AN IPSILATERAL APPROACH WAS MADE. THE TARGET LESION WAS THE RIGHT COMMON ILIAC ARTERY. THE PATIENT¿S INFORMATION, VESSEL LEVEL OF TORTUOUSNESS, CALCIFICATION AND RATE OF STENOSIS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6584320 ↗

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