Cordis S.M.A.R.T. Control Vascular Stent System C08100MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032024225), received between Nov 29, 2017 and Jan 13, 2021 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 9MM X 40MM SMART CONTROL SELF-EXPANDING STENT WAS IMPLANTED IN THE COMMON ILIAC ARTERY (CIA) AND AN 8MM X 4CM UNKNOWN BALLOON CATHETER PERFORMED A POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). AFTER THAT, ANGIOGRAPHY REVEALED DISSOCIATION IN THE EXTERNAL ILIAC ARTERY. THEREFORE, AN 8MM X 100MM SMART CONTROL SELF-EXPANDING STENT WAS ATTEMPTED TO BE IMPLANTED AT THE DISSOCIATION PART. HOWEVER, THE UNKNOWN SHEATH CAME OUT FROM THE PATIENT BODY FROM THE FEMORAL ARTERY. SO, THE 8MM X 100MM SMART CONTROL STENT COULD NOT BE INSERTED FROM THE FEMORAL ARTERY. IT WAS ATTEMPTED TO BE INSERTED FROM THE LEFT BRACHIAL; SO, THE SHEATH WAS CHANGED TO ANOTHER 6F NON-CORDIS SHEATH. HOWEVER, THE SMART CONTROL STENT INTERFERED; AND IT WAS JUDGED THAT THE INSERTION FROM THE BRACHIAL WAS IMPOSSIBLE. A 6F 11CM UNKNOWN SHEATH WAS THEN INSERTED IN THE RIGHT FEMORAL ARTERY. DURING DEPLOYMENT OF THE 8MM X 100MM SMART CONTROL STENT, THE DOCTOR CONTROLLED THE POSITION BECAUSE THE ¿PROXY¿ SIDE WAS CLOSE TO THE PUNCTURE SITE. IT SEEMS THAT THE STENT WAS FOUND TO BE OUT OF THE BLOOD VESSEL ON THE WAY. THE DOCTOR TRIED TO PUT BACK THE STENT INTO THE VESSEL, BUT IT COULD NOT. THE DOCTOR DECIDED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164169 ↗
• MalfunctionAug 24, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 8MM X 100MM ILIAC SMART CONTROL STENT WOULD NOT DEPLOY. ADDITIONAL INFORMATION WAS RECEIVED AND PER VISUAL ANALYSIS, THE STENT OF THE UNIT WAS OBSERVED DEPLOYED APPROXIMATELY 3 MM FROM THE UNIT. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION IS A STRAIGHTFORWARD SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445906 ↗
• MalfunctionJun 18, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 8X100 SMART CONTROL SELF-EXPANDING STENT (SES) ILIAC WAS DELIVERED TO THE LESION. HOWEVER, IT WAS SPINNING AROUND, AND THE STENT COULD NOT BE DEPLOYED WHEN THE DOCTOR TURNED THE DIAL TO TRY TO DEPLOY. THEREFORE, IT WAS REPLACED WITH A NEW SMART CONTROL STENTS 8X80 AND 10X60 WHICH COULD BE DEPLOYED, AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION OBTAINED FROM THE PRODUCT ANALYSIS STATES THE SMART CONTROL STENT WAS RECEIVED PARTIALLY DEPLOYED APPROXIMATELY 18 MM FROM THE UNIT. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE LESION WAS THE ILIAC ARTERY WHICH HAD STENOSIS. AN APPROACH WAS MADE FROM THE BRACHIAL ARTERY. A NON-CORDIS GUIDING CATHETER WAS USED. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THERE WAS LITTLE VESSEL TORTUOSITY. THE LESION HAD LITTLE CALCIFICATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10169356 ↗
• MalfunctionSep 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AN 8 X 100 ML SMART CONTROL ILIAC STENT WAS INSERTED AND THE DOCTOR ATTEMPTED TO DEPLOY THE STENT. HOWEVER, THEY COULD NOT TURN THE DIAL OF THE CONTROL HANDLE COMPLETELY. THE DOCTOR TURNED THE DIAL, BUT THE DIAL RETURNED TO THE FORMER POSITION. THE DOCTOR MANAGED TO IMPLANT THE STENT WHILE THEY HELD THE DIAL. ACCORDING TO MANUFACTURER EVALUATION OF THE RETURNED PRODUCT, DURING VISUAL ANALYSIS, A SEPARATED CONDITION WAS DETECTED ON THE BODY SHAFT OF THE UNIT AT 3.3 CM FROM THE ID BAND. THERE WAS NO PATIENT INJURY REPORTED. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS NOT CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE DEVICE WAS STORED, HANDLED, INSPECTED, AND PREPARED AS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE INTENDED PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LESION HAD LITTLE CALCIFICATION, AND MODERATE TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THERE WAS NO DIFFICULTY ADVANCING THE SDS OVER THE GUIDEWIRE OR EMBOLIC PROTECTION DEVICE. THE DELIVERY OF THE SDS TO THE LESION WAS IPSI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070650 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(4), APPROXIMATELY THIRTY-NINE MONTHS POST IMPLANTATION OF THREE SMART (SMART 120 150, SFA - 7X120MM, 8X120MM, SMART CONTROL, ILIAC 8X100ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT HAD INTERMITTENT CLAUDICATION APPEARED AND ALSO A RIGHT SUPERFICIAL FEMORAL ARTERY OCCLUSION AND STENOSIS OF THE RIGHT COMMON FEMORAL ARTERY ORIGIN WAS CONFIRMED BY DOPPLER ULTRASOUND (DUS). A TREATMENT PLAN WAS GOING TO BE DETERMINED THE NEXT TIME THE PATIENT VISITS THE HOSPITAL. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

  Patient problems: Claudication; Occlusion; Stenosis

  MAUDE report 7068049 ↗

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