Cordis S.M.A.R.T. Control Vascular Stent System C07100MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032023921), received between Jan 21, 2019 and Mar 9, 2023 — classified as 3 malfunctions.

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

• MalfunctionMar 9, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A SMART CONTROL ILIAC 7X100 SELF-EXPANDING STENT DID NOT DEPLOY PROPERLY. THE PHYSICIAN PULLED THE PIN AND PARTIALLY DEPLOYED THE STENT USING THE THUMB WHEEL. AFTER THE STENT STARTED TO OPPOSE THE VESSEL WALL THE PHYSICIAN CONVERTED TO THE SLIDE BUT THE STENT DID NOT DEPLOY SMOOTHLY BUT FOLDED IN ON ITSELF AND THEN CONTINUED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE A RIGHT LEG ANGIOGRAM; RECANALIZATION OF RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS THE RIGHT SFA. LESION CHARACTERISTICS INCLUDED MODERATE LESION CALCIFICATION WITH NO VESSEL TORTUOSITY AND EIGHTY PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE PREPPED PER THE IFU WITHOUT DIFFICULTY. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH WHEN REMOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519268 ↗
• MalfunctionSep 2, 2021Difficult or Delayed Positioning; Material Split, Cut or Torn; Difficult or Delayed Positioning; Material Split, Cut or Torn

  AS REPORTED, THE 7MM X 100MM ILIAC SMART CONTROL SELF-EXPANDING STENT (SES) SYSTEM WAS BEING INSERTED INTO THE BODY AND BEGAN TO UNSHEATHE AND FLOWER OUT. THE STENT BEGAN TO DEPLOY WHILE RED SAFETY CLIP WAS STILL IN PLACE. THE STENT WAS REMOVED, AND NEW STENT (UNKNOWN) WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELING AND OPENED IN STERILE FIELD. 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 AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. WHEN REMOVED FROM THE TRAY, THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THE INTENDED VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7F NON CORDIS SHEATH INTRODUCER WAS USED. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE HANDLE OF THE SMART CONTROL SDS W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413496 ↗
• MalfunctionJan 21, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 7X100ML ILIAC SMART CONTROL STENT WAS INSERTED, HOWEVER IT DID NOT CROSS THE LESION. THE STENT WAS REMOVED FROM THE PATIENT AND THE BALLOON CATHETER WAS INFLATED AGAIN. THEN THE SMART CONTROL STENT WAS INSERTED AGAIN, HOWEVER THE SAME ISSUE OCCURRED. IT WAS CONFIRMED THAT THERE WAS SOME GAP BETWEEN THE OUTER SHEATH AND DISTAL TIP. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS STORED IN THE CATH LAB ON A SHELF FOR ABOUT THREE MONTHS. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU), THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE, THE DEVICE PREPPED NORMALLY, AND THE STENT WAS NOT MANIPULATED DURING PREP. IT WAS VERIFIED PRIOR TO INSERTION THAT STENT WAS CONTAINED WITHIN THE OUTER SHEATH/INTRODUCER OF THE SYSTEM. THE GUIDEWIRE PORT WAS FLUSHED AS OUTLINED IN THE IFU PRIOR TO LOADING ON THE GUIDEWIRE. A NON-CORDIS SHEATH WAS USED. THE LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD SEVERE CALCIFICATION, FIFTY PERCENT STENOSIS, HAD NO VESSEL TORTUOSITY/ANGULATION, AND THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). A CONTRALATERAL APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. A NON-CORDIS BALLOON CATHETER PERFOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264066 ↗

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