Cordis S.M.A.R.T. Control Vascular Stent System C10040MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032024591), received between Oct 3, 2017 and Sep 30, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Mar 4, 2025Class IIOpen, Classified

   product mix-up; Vascular stent labeled as one size but contains a different size.

   Z-1510-2025 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TUNING DIAL ON A 10 X 40ML ILIAC SMART CONTROL VASCULAR STENT SYSTEM WAS UNABLE TO BE TURNED ALL THE WAY. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER DIFFERENT SIZED DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY. THE LESION WAS THE SUBCLAVIAN ARTERY WHICH WAS STENOSED. AN APPROACH WAS MADE FROM THE FEMORAL ARTERY. A 6FR 90CM NON-CORDIS SHEATH WAS USED. THE SMART CONTROL DEVICE WAS ATTEMPTED TO BE IMPLANTED. AFTER THE INCIDENT, THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT TO OBSERVE. THE OUTER SHEATH HAD BEEN RETRACTED UNTIL THE STENT WAS ABOUT TO COME OUT. THE TUNING DIAL HAD BEEN RETRACTED TOWARDS THE PROXIMAL PART FROM THE ORIGINAL POSITION. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: A SEPARATION ON THE INNER LUMEN AND A SEVERE KINK WERE OBSERVED ON THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510710 ↗
• MalfunctionJan 17, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A 6F 45CM NON-CORDIS GUIDING SHEATH, A 4F VERTEBRAL TEMPO CATHETER AND A 0.035 NON-CORDIS GUIDEWIRE, HOWEVER, THE DEVICES WERE NOT ABLE TO CROSS THE STENOSIS LESION. THEREFORE, THE DEVICES WERE REMOVED AND REPLACED WITH ANOTHER NON-CORDIS GUIDEWIRE TOGETHER WITH A NON-CORDIS MICRO CATHETER AND THEY WERE ABLE TO CROSS THE LESION. A NON-CORDIS EXTENSION CATHETER WAS USED HOWEVER, THE SAME ISSUE CONTINUED. THEREFORE, THE PHYSICIAN INSERTED A NON-CORDIS SHEATH FROM THE LEFT BASILAR ARTERY AND A PULL-THROUGH OPERATION WAS PERFORMED WITH AN UNKNOWN SNARE BY CATCHING THE CRUISE. A NON-CORDIS INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS INSERTED HOWEVER, WAS NOT ABLE TO CROSS THE LESION. THEREFORE, TWO NON-CORDIS BALLOON CATHETERS INFLATED THE LESION AND THE NON-CORDIS IVUS CATHETER CROSSED THE LESION. A 10 X 40 SMART CONTROL ILIAC STENT WAS INSERTED HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP WAS FRAYED, AND ANOTHER SAME SIZE SMART STENT AND A NON-CORDIS MICRO-CATHETER WERE INSERTED TOGETHER AND THE DEVICES WERE ABLE TO CROSS THE L

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9602701 ↗
• InjuryOct 3, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED, THE PATIENT WAS ENROLLED IN A CLINICAL STUDY, (B)(6). THE PATIENT HAD TWO (2 EACH) SMART CONTROL STENTS IMPLANTED SUCCESSFULLY DURING THE STUDY INDEX PROCEDURE WITH NO REPORTED ISSUE: A SMART CONTROL ILIAC 8 X 60, AND A SMART CONTROL ILIAC 10 X 40. THE TARGET LESION WAS THE DISTAL PORTION OF THE LEFT FEMORAL ARTERY (LFA). NO TARGET LESION CHARACTERISTIC INFORMATION INCLUDING PERCENT STENOSIS WAS PROVIDED. THREE YEARS ELEVEN MONTHS AND FOURTEEN DAYS AFTER THE INDEX PROCEDURE, THE PATIENT VISITED THE HOSPITAL FOR A PERIODIC EXAMINATION AND ECHOGRAPHY WAS DONE TO THE LEFT SUPERFICIAL FEMORAL ARTERY. THEN A RESTENOSIS IN THE STENT(S) WAS CONFIRMED. SINCE THE PATIENT HAVE A LIGHT SYMPTOM, NO TREATMENT WAS APPLIED AND WILL BE FOLLOWED UP. THE PATIENT WAS NOT RECOVERED. THE RELEVANCY WITH THE PRODUCT: NONE (PRIMARY DISEASE). THE RELEVANCY WITH THE PROCEDURE: NONE (PRIMARY DISEASE). ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE TARGET LESION FOR THE PATIENT¿S INDEX PROCEDURE WAS THE DISTAL PORTION OF THE LEFT FEMORAL ARTERY. IT WAS UNKNOWN IF THE TWO STENTS THAT WERE IMPLANTED DURING THE INDEX PROCEDURE WERE IMPLANTED IN OVERLAPPING FASHION. THE LIGHT SYMPTOMS THE PATIENT

  Patient problems: Reocclusion

  MAUDE report 6911805 ↗

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-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