Cordis S.M.A.R.T. Control Vascular Stent System C06060MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032023532), received between Feb 21, 2017 and Oct 3, 2022 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionOct 3, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, DURING THE ATTEMPTED INSERTION OF A 6MM X 60MM S.M.A.R.T. CONTROL ILIAC SELF-EXPANDING STENT (SES) DELIVERY SYSTEM OVER A 260MM .035 AQUATRACK GUIDEWIRE, THE PHYSICIAN NOTICED THE STENT WAS PARTIALLY UNSHEATHED AT THE DISTAL END. AS A RESULT, THE DEVICE WAS NEVER ENTERED INTO THE PATIENT, AND A 6MM X 80MM 120CM S.M.A.R.T. CONTROL SES WAS USED INSTEAD AND WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO 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 DEVICE WAS STORE, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY FLUSHING THE STOPCOCK OR THE DELIVERY SYSTEM ITSELF. THE STENT DID NOT APPEAR PREMATURELY EXPOSED WHEN THE DEVICE WAS REMOVED FROM ITS TRAY. IT WAS REPORTED THAT THE RED SAFETY PIN WAS STILL IN PLACE WHEN THE MALFUNCTION WAS OBSERVED. AFTER REMOVAL OF THE DEVICE, THE STENT WAS ABLE TO BE UNSHEATHED FROM THE DELIVERY SYSTEM. ADDITIONALLY, THERE WAS NO DAMAGE TO THE AQUATRACK GUIDEWIRE THAT WAS USED DURING THIS PROCEDURE. THE STENT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533756 ↗
• MalfunctionDec 5, 2017Material Frayed; Torn Material; Material Frayed; Torn Material

  A BALLOON CATHETER (3 MM*10 CM) INFLATED IN THE LESION AS A PRE-DILATATION, AND A SMART CONTROL, ILIAC 6 X 60 ML STENT WAS INSERTED. HOWEVER THERE WAS RESISTANCE FELT DURING DELIVERY AND REMOVED. THEN THE DISTAL TIP WAS CONFIRMED TO BE FRAYED. THEREFORE IT WAS REPLACED WITH A NEW SMART CONTROL. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS, CALCIFICATION AND RATE OF STENOSIS WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084281 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY, A SMART 120 150, SUPERFICIAL FEMORAL ARTERY (SFA) - 6 X 150 MM STENT AND A SMART CONTROL, ILIAC 6 X 60 ML STENT WERE IMPLANTED IN THE TARGET LESION WITHOUT ANY ISSUE. APPROXIMATELY 4 YEARS, 2 MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED ASYMPTOMATIC STENT THROMBOSIS. ABI AND DUS CONFIRMED THE OCCLUSION. THE THROMBOSIS WAS INSIDE AND THE EDGE OF THE STENT(S). RUTHERFORD EXAM WAS NOT DONE, AND NO TREATMENT WAS APPLIED. THE PATIENT WAS A (B)(6) FEMALE. THE TARGET LESION WAS THE MIDDLE PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS MILDLY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: Thrombosis

  MAUDE report 7084093 ↗
• InjuryAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A SMART CONTROL STENT IN THE TARGET LESION WITHOUT ISSUE. THE PATIENT WAS A (B)(6)-OLD MALE AND THE ORIGINAL TARGET LESION WAS THE PROXIMAL PORTION OF THE LEFT FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. APPROXIMATELY THREE YEARS AND 6 MONTHS AFTER THE INDEX PROCEDURE, A RESTENOSIS IN THE LOWER LEG WAS CONFIRMED VIA ECHOGRAPHY. A MONTH AFTER, A REVASCULARIZATION WAS PERFORMED IN THE TARGET LESION AND THE PATIENT RECOVERED. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: Reocclusion; Vascular System (Circulation), Impaired

  MAUDE report 6787700 ↗
• MalfunctionFeb 21, 2017Detachment Of Device Component; Difficult To Position; Detachment Of Device Component; Difficult To Position

  AS REPORTED, THE SMART CONTROL ILIAC 6 X 60 ML. STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE SUPERFICIAL FEMORAL ARTERY LESION. THERE WAS NO PATIENT INJURY. AFTER FAL PRODUCT ANALYSIS, THE CATHETER TIP WAS NOT RECEIVED WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6344997 ↗

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