Cordis S.M.A.R.T. Control Vascular Stent System C07060MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032023839), received between Nov 19, 2020 and May 5, 2023 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  AS REPORTED, A 7MM X 60MM SMART CONTROL STENT FAILED TO DELIVER OUT OF THE SHEATH. THE STENT SOMEHOW STARTED TO DEPLOY ONCE IT REACHED THE TIP OF THE SHEATH. IT WAS THAN STUCK TO THE SHEATH. WE HAD TO PULL THE SHEATH AND START AGAIN. THE CASE WAS COMPLETED WITH ANOTHER SMART CONTROL. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE USER WAS EXPERIENCED IN USING THE DEVICE. THERE WERE NO ADVERSE EVENTS AFTER THE BACK-UP STENT WAS USED. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH AFTER REMOVED FROM THE TRAY. THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE SDS. THE LESION WAS MEASURED TO BE 6MM IN DIAMETER. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN THE VESSEL DIAMETER. THE SDS DID NOT PASS THROUGH ANY ACUTE BENDS. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. UN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876477 ↗
• MalfunctionFeb 24, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  A 7X 60 ILIAC SMART CONTROL SELF EXPANDING STENT WAS INSERTED VIA A RIGHT FEMORAL ARTERY ACCESS, BUT IT WAS UNABLE TO CROSS THE LESION BETWEEN THE LEFT EXTERNAL ILIAC ARTERY AND THE COMMON FEMORAL ARTERY. THEREFORE, THE LESION WAS INFLATED THERE WITH THE BALLOON CATHETER. THE PHYSICIAN ATTEMPTED TO DELIVER THE SMART CONTROL STENT AGAIN, BUT THE DISTAL TIP WAS FRAYED. IT WAS REPLACED WITH A NON-CORDIS STENT. THE BALLOON CATHETER WAS USED FOR POST-DILATION. THE LESION WAS NOT INFLATED ENOUGH SLIGHTLY BUT GOOD FLOW WAS CONFIRMED. THE PROCEDURE COMPLETED. THE LESION WAS A CHRONIC TOTAL OCCLUSION AND HAD SEVERE CALCIFICATION. A GUIDEWIRE CROSSED THE LESION AND PRE-DILATATION WAS PERFORMED WITH A NON-CORDIS BALLOON CATHETER. THE SALES REP CANNOT VISIT THE HOSPITAL BECAUSE OF THE COVID-19. THEREFORE, ADDITIONAL INFORMATION CANNOT BE OBTAINED. THE DEVICE WAS DISCARDED DUE TO SUSPICIOUS INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595071 ↗
• MalfunctionNov 19, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 7 X 60 SMART CONTROL SELF-EXPANDING STENT DELIVERY SYSTEM WAS DELIVERED ALONG THE NON-CORDIS GUIDEWIRE; HOWEVER, IT GOT STUCK IN THE NON-CORDIS GUIDING SHEATH. THE DOCTOR PULLED ITS HANDLE AND TRIED TO REMOVE IT; HOWEVER, THE STENT WAS DEPLOYED IN THE GUIDING SHEATH. THEREFORE, ALL DEVICES WERE REMOVED FROM THE PATIENT BODY AND THE PROCEDURE WAS INTERRUPTED. THERE WAS NO REPORTED PATIENT INJURY. A BRACHIAL APPROACH WAS MADE WITH A 6F NON-CORDIS GUIDING SHEATH. A 0.014¿ NON-CORDIS GUIDEWIRE WAS DELIVERED INTO THE LEFT ILIAC ARTERY. ANOTHER 0.035¿ NON-CORDIS GUIDEWIRE WAS DELIVERED INTO THE RIGHT ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10867860 ↗

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