Cordis S.M.A.R.T. Control Vascular Stent System C08080MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032024171), received between Nov 11, 2021 and Sep 24, 2022 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, AN ENDOVASCULAR THERAPY (EVT) PROCEDURE WAS BEING PERFORMED TO TREAT A CHRONIC TOTALLY OCCLUDED (CTO) COMMON ILIAC ARTERY (CIA) LESION, AND A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. AN UNKNOWN GUIDEWIRE WAS INSERTED AND CROSSED THE CIA LESION, WHICH WAS FOLLOWED BY THE USE OF AN 8MM X 4CM 155CM SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO PERFORM A BALLOON ANGIOPLASTY AT THE CIA LESION. THE SABERX PTA BALLOON CATHETER WAS THEN USED TO TREAT THE DISTAL SFA LESION. AN 8MM X 80MM S.M.A.R.T. CONTROL ILIAC SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS THEN INSERTED AND IMPLANTED IN THE CIA. AFTER IMPLANTATION OF THE SES, A PERFORATION OF THE CIA WAS CONFIRMED, AND AN ADDITIONAL ACCESS WAS MADE RETROGRADELY IN ORDER TO INSERT THE 8MM X 4CM SABERX PTA BALLOON CATHETER TO BE USED FOR HEMOSTASIS OF THE PERFORATED CIA. AFTER THE USE OF THE SABERX PTA BALLOON, TWO NON-CORDIS STENTS OF UNKNOWN SIZES WERE IMPLANTED. HEMOSTASIS WAS CONFIRMED AND THE PROCEDURE WAS COMPLETED. AFTER COMPLETION OF THE PROCEDURE, RE-BLEEDING FROM THE CIA LESION WAS CONFIRMED. THE PHYSICIAN TRIED TREATMENT, BUT THE PATIENT PASSED AWAY THE FOLLOWING DAY. BOTH DEVICES WERE DISCAR

  Patient problems: Perforation of Vessels

  MAUDE report 15479848 ↗
• MalfunctionNov 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A SMART CONTROL ILIAC 8X80ML STENT WAS USED AND ATTEMPTED TO BE DEPLOYED. THE DOCTOR TURNED ITS TUNING DIAL; HOWEVER, THE STENT WAS NOT DEPLOYED. THEREFORE, IT WAS REPLACED WITH A NEW SMART CONTROL STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD NO INFECTIOUS DISEASE. THE LESION WAS THE COMMON ILIAC ARTERY. A BRACHIAL APPROACH WAS MADE. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE OUTER MEMBER AND SUPPORT MEMBER (INNER SHAFT) OF THE UNIT WERE OBSERVED BROKEN/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800193 ↗

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