Cordis S.M.A.R.T. Control Vascular Stent System C06040MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032023495), received between Oct 15, 2016 and Dec 7, 2020 — classified as 1 death, 1 injury, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 6 X 40 SMART CONTROL ILIAC SELF-EXPANDING STENT (SES) WAS USED BUT IT WAS DIFFICULT TO CROSS THE LESION BECAUSE OF SEVERE TORTUOUS BLOOD VESSEL; 10CM BEFORE REACHING THE LESION, THE PHYSICIAN PUSHED THE SHAFT MORE. THE STENT WAS DEPLOYED APPROXIMATE 5MM EVEN THOUGH HE DID NOT TOUCH THE TUNING DIAL. THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS REPLACED WITH A 6 X 60 SMART CONTROL ILIAC SELF-EXPANDING STENT (SES). HOWEVER, THIS DEVICE WAS NOT ABLE TO CROSS THE LESION, NEITHER. THE PROCEDURE WAS COMPLETED BY PERFORMING PLAIN OLD BALLOON ANGIOPLASTY (POBA). THERE WAS NO REPORTED PATIENT INJURY. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE DEVICES WERE STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE LESION WAS THE STENOSIS AT THE SUPERFICIAL FEMORAL ARTERY. THE SFA TARGET LESION VESSEL WAS 5MM IN DIAMETER AND 4CM IN LENGTH. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960750 ↗
• MalfunctionApr 7, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE DISTAL END OF THE TIP OF 6X40ML SMART CONTROL ILIAC VASCULAR STENT SYSTEM WAS DEPLOYED A LITTLE AND IT COULD NOT BE DELIVERED. LESS THAN 1CM, ABOUT 2-3 STRUTS OF THE STENT HAD BEEN PRE-MATURELY DEPLOYED. A CONTRAST WAS IMMEDIATELY NECESSARY TO BE APPLIED BEFORE PULLING OUT AND HOLDING THE RED LOCKING PIN. THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY AND WAS INSERTED AGAIN. IT WAS SUSPECTED THAT THIS OPERATION SEEMED TO BE THE CAUSE OF THE PREMATURE DEPLOYMENT OF THE STENT. THEREFORE, IT WAS REPLACED WITH A NEW SMART CONTROL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO IFU. THERE WAS NO DAMAGE NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE TYPE OF PROCEDURE WAS ENDOVASCULAR THERAPY (EVT). THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION HAS SEVERE CALCIFICATION WITH NO VESSEL TORTUOSITY. THERE WAS 90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. WHEN THE DEVICE WAS REMOVED FROM THE TRAY, THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THE TEMPE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933302 ↗
• DeathNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, APPROXIMATELY FIVE YEARS POST IMPLANTATION OF THE SMART CONTROL (ILIAC 6X40ML) SELF¿EXPANDING STENT (SES) ON THE PROXIMAL PORTION OF THE RIGHT FEMORAL ARTERY, THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF HEART FAILURE AND THE PATIENT EXPIRED FIVE DAYS LATER. THE EVENT IS CONSIDERED NOT RELATED TO THE INDEX PROCEDURE OR THE DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE OFFICIAL CAUSE OF DEATH WAS HEART FAILURE. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO HIS DEATH.

  Patient problems: Death; Heart Failure

  MAUDE report 8051340 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, FOUR YEARS POST IMPLANTATION OF A SMART (SMART CONTROL, ILIAC 6 X 40 ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT HAD INTERMITTENT CLAUDICATION APPEARED AND HEAVY STENOSIS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, ALSO THE PATIENT HAD INTERMITTENT CLAUDICATION APPEARED AND STENOSIS IN FRONT OF THE STENT IN THE LESION AND OCCLUSION IN THE STENT BOTH WERE CONFIRMED BY VESSEL ECHOGRAPHY. AN ENDOVASCULAR REPAIR PROCEDURE WAS PERFORMED TO THE PATIENT ON AN UNKNOWN DATE. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

  Patient problems: Claudication; Occlusion; Stenosis

  MAUDE report 7068296 ↗
• MalfunctionOct 15, 2016Premature Activation; Premature Activation

  AS REPORTED, DURING A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE WITH AN INITIAL NON-CORDIS STENT PLACED AT THE OSTIUM, A SMART 120 150 SFA 7 X 150 MM. AND A SMART CONTROL ILIAC 6 X 40ML. APPEARED TO GET HUNG UP ON THE NON-CORDIS STENT AND UNSHEATH DURING ADVANCEMENT. AFTER SEVERAL ATTEMPTS THEY WERE REMOVED AND STILL INTACT. OTHER SMART STENTS WERE USED AND THE OUTCOME WAS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6032155 ↗

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