Cordis S.M.A.R.T. Control Vascular Stent System C10030SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032024577), received between Jul 5, 2018 and Jun 16, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PHYSICIAN WENT TO START DEPLOYING THE SMART CONTROL 10X30 STENT, SLOWLY MOVING THE CONTROL WHEEL AND THE STENT JUMPED OFF THE RAIL AND DEPLOYED DISTAL TO WHERE THE TARGET LESION WAS. A SMART CONTROL 10X40 WAS USED TO COMPLETE THE CASE. NO HARM/INJURY WAS DONE TO THE PATIENT AND ANOTHER STENT HAD TO BE USED TO COVER THE LESION. THE STENT WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS ALSO NOTED THAT THERE WERE NO ISSUES WITH THE STENT. IT WAS NOTED THAT THERE WAS NO RESISTANCE DEPLOYING THE STENT AS THE STENT JUMPED OFF THE RAIL SYSTEM. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. NOTHING UNUSUAL WAS NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH AFTER REMOVAL FROM THE TRAY. A STOPCOCK WAS CONNECTED TO THE Y-CONNECTOR OF THE TUOHY BORST VALVE. THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE STOPCOCK OR THE SDS. A 6F SHEATH WAS USED FOR THE PROCEDURE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS NOTED NOT TO BE REMOVED BEFORE ATT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14709575 ↗
• InjuryMay 21, 2022Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration

  AS REPORTED, THE PHYSICIAN WAS DEPLOYING THE SMART CONTROL ILIAC 10X30 STENT; HOWEVER, THE PHYSICIAN VISUALIZED THAT THE STRUTS AND RADIOPAQUE MARKERS OF THE STENT AND STOPPED TO CONFIRM POSITIONING UNDER FLUORO BEFORE DEPLOYMENT, HE WAS NOT MOVING THE ROLLER IN ANY DIRECTION, DURING THAT PAUSE IS WHEN THE PHYSICIAN NOTICED THE STENT HAD SLID/ JUMPED OFF THE DEPLOYMENT SYSTEM. ANOTHER STENT HAD TO BE PLACED AS THE STENT HAD MOVED TOO FAR FORWARD AND MISSED THE LANDING ZONE FOR THE LESION. THE ADDITIONAL STENT EXPAND FULLY WITH GOOD WALL APPOSITION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH AFTER REMOVED FROM THE PACKAGE. A STOPCOCK WAS CONNECTED TO THE Y-CONNECTOR OF THE TUOHY BORST VALVE. THERE WAS NO DIFFICULTY NOTED WHILE FLUSHING THE STOPCOCK OR WHILE FLUSHING THE SD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465473 ↗
• InjuryApr 28, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A 10X30 ILIAC SMART STENT WAS INSERTED FROM THE LEFT BRACHIAL REGION AND BEING DELIVERED, HOWEVER, THE STENT ¿ADVANCED AND FELL DOWN THE AORTA. AFTER THAT, THE DEVICE LOCKED TO THE PLAQUE IN THE MIDDLE OF THE DESCENDING AORTA. THE DOCTOR DECIDED TO FOLLOW UP WITHOUT ANY ADDITIONAL TREATMENT.¿ THIS WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE FROM THE BRACHIOCEPHALIC ARTERY. A 6F NON-CORDIS GUIDING SHEATH WAS INITIALLY INSERTED FROM THE LEFT BRACHIAL REGION. A 014 NON-CORDIS GUIDEWIRE CROSSED THE LESION AND A 5X30 NON-CORDIS BALLOON CATHETER WAS USED FOR PRE-DILATION. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246559 ↗
• MalfunctionJul 5, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING USE, IT WAS REPORTED THAT THE SMART CONTROL STENT WAS INACCURATELY PLACED. THERE WAS NO PATIENT INJURY. THE LESION WAS THE SUBCLAVIAN ARTERY WITH STENOSIS. A BRACHIAL APPROACH WAS MADE WITH A 6F COMPETITOR'S GUIDING CATHETER AND A COMPETITOR'S GUIDEWIRE CROSSED THE LESION. THEN A SMART CONTROL STENT WAS DELIVERED AND IMPLANTED. HOWEVER, IT JUMPED AND THE STENT WAS IMPLANTED IN THE DISTAL OF THE LESION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663988 ↗

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