Cordis S.M.A.R.T. Control Vascular Stent System C07040MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032023792), received between Nov 27, 2017 and May 3, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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

• MalfunctionMay 3, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE SMART CONTROL STENT WAS ATTEMPTED TO BE DELIVERED TO THE LESION, BUT THE DISTAL TIP WAS FRAYED. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER, BIGGER SIZED SMART STENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS AN ILIAC CASE. PRE-DILATION WAS PERFORMED. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (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 WHEN THE DEVICE WAS REMOVED FROM THE TRAY. A NON-CORDIS SHEATH WAS USED FOR THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860738 ↗
• InjuryNov 21, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, AN ILIAC 7 X 40ML SMART CONTROL VASCULAR STENT JUMPED 2/3 OF THE LENGTH OF THE STENT UPON PLACEMENT INTO THE SUBCLAVIAN ARTERY. A SECOND 8MM X 30MM SMART STENT WAS THEN DEPLOYED TO ACT AS AN ANCHOR FOR THE INITIAL STENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE STENT WAS BEING PLACED IN THE LEFT SUBCLAVIAN VEIN AT THE ANASTOMOSIS OF THE "LEFT JUGULAR". THE PROXIMAL MARKER OF THE STENT WAS PLACED RIGHT AT THE JUGULAR VEIN AND THE DISTAL MARKER OF THE STENT WAS PLACED INTO THE "SUBCLAVIAN". UPON INITIATING DEPLOYMENT OF THE DEVICE, THE STENT JUMPED CENTRALLY INTO THE BRACHIOCEPHALIC VEIN LEAVING 1/3 OF THE STENT INTO THE SUBCLAVIAN ARTERY. POST- PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PREFORMED TO ENSURE THAT THE STENT DID NOT MOVE CENTRALLY. 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 PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE TARGET LESION VESSEL DIAMETER WAS 5.5MM. A 6F CORDIS BRITE TIP SHEATH WAS USED. THE DIAMETER OF THE UNCONSTRAINED STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15832619 ↗
• MalfunctionApr 16, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, THE 7 X 40 SMART CONTROL ILIAC SELF-EXPANDING STENT (SES) WAS DELIVERED ALONG THE 35-INCH NON-CORDIS WIRE. HOWEVER, IT GOT STUCK IN THE MIDDLE. IT FELT LIKE IT WAS DELIVERED TO THE CONTROLLER, BUT IT COULD NOT PROCEED FROM THERE. THE NON-CORDIS WIRE DID NOT COME OUT FROM THE GUIDE WIRE PORT, SO IT WAS REMOVED FROM THE PATIENT¿S BODY. THEREFORE, IT WAS REPLACED WITH A NEW SMART CONTROL STENT AND IT COULD BE IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY. ANALYSIS OF THE RETURNED DEVICE INDICATED THE OUTER SHEATH WAS TORN AT APPROXIMATELY 6CM FROM THE STRAIN RELIEF AND THE BRAID WIRES WERE OBSERVED EXPOSED ON THE TORN AREA. THE SMART CONTROL STENT WAS ATTEMPTED TO BE IMPLANTED AT THE SUPERIOR MESENTERIC ARTERY (SMA). A 35-INCH NON-CORDIS WIRE WAS INSERTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680615 ↗
• MalfunctionOct 22, 2019Fracture; Fracture

  AS REPORTED, THE DISTAL END TIP OF A 7X40ML SMART CONTROL, ILIAC STENT WAS INSERTED AND GOT KINKED 90 DEGREES ANGLE DUE TO INADEQUATE INFLATION CAUSED BY SEVERE CALCIFICATION. THERE WAS A GAP NOTED BETWEEN THE DISTAL TIP AND THE GUIDEWIRE LUMEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAS SEVERE CALCIFICATION WITH STENOSIS. A CONTRALATERAL APPROACH WAS MADE. THE LESION WAS INFLATED WITH A NON-CORDIS BALLOON CATHETER (BC) FOR PRE DILATION AFTER A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE PATIENT HAS NO INFECTIOUS DISEASE. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED IN THE HOSPITAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9218415 ↗
• MalfunctionDec 12, 2018Premature Activation; Premature Activation

  AS REPORTED, A SMART CONTROL STENT WAS ATTEMPTED TO BE DELIVERED TO THE LESION, HOWEVER IT COULD NOT CROSS. THERE WAS NO REPORTED PATIENT INJURY. IT WAS REPLACED WITH A NEW NON-CORDIS STENT AND IT WAS IMPLANTED WITHOUT ANY ISSUES. TWO SMART STENTS WERE IMPLANTED IN THE LEFT ILIAC ARTERY AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE LEFT ILIAC ARTERY AND THE LEFT SUPERFICIAL FEMORAL ARTERY WITH SEVERE CALCIFICATION. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. A NON-CORDIS BALLOON CATHETER WAS INFLATED AS A PRE-DILATION. WHEN THE SMART CONTROL STENT WAS UNABLE TO CROSS, THE PHYSICIAN REMOVED IT AND TRIED TO CROSS IT AGAIN AFTER A SECOND PRE DILATION WITH THE NSE BALLOON CATHETER. BUT THE SAME ISSUE OCCURRED AGAIN. IT WAS CONFIRMED THAT THERE WAS SOME GAP BETWEEN ITS OUTER SHEATH AND ITS DISTAL TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157826 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED THE SMART CONTROL STENT IN THE TARGET LESION WITHOUT ANY ISSUE. TWO YEARS LATER, THE PATIENT HAD CLAUDICATION ON THE RIGHT LEG AND OCCLUSIVE THROMBOSIS WAS CONFIRMED IN THE STENT. A FOGARTY PROCEDURE WAS PERFORMED THE NEXT DAY AND THE PATIENT RECOVERED. THREE YEARS AFTER THE PROCEDURE, THE PATIENT EXPIRED. THE PATIENT¿S DEATH IS UNKNOWN. THE TARGET LESION WAS THE DISTAL PORTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THIS IS A CASE FROM (B)(4) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(4).

  Patient problems: Occlusion

  MAUDE report 7060435 ↗

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