Cordis S.M.A.R.T. Control Vascular Stent System C06080MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032023570), received between Feb 10, 2017 and Dec 17, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.

• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A CASE FROM (B)(6). A SMART STENT AND A SMART CONTROL STENT WAS IMPLANTED IN THE MIDDLE PORTION OF THE RIGHT FEMORAL ARTERY. FIVE YEARS LATER, LOWER EXTREMITY ARTERIOGRAPHY CONFIRMED IN-STENT RE-OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN UNKNOWN BALLOON CATHETER WAS USE FOR DILATION AND A STENT WAS IMPLANTED. THE ABI LEVEL OF THE LESION HAVE BEEN DECREASE AND WAS CONFIRMED TO BE 0.52 AND 0.98. THE RIGHT BELOW THE KNEE HAD A PAIN WHEN THE PATIENT RESTED. TARGET LESION WAS REVASCULARIZATION WAS PERFORMED AND THE PATIENT RECOVERED.

  Patient problems: Occlusion

  MAUDE report 8169398 ↗
• MalfunctionFeb 10, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A PROCEDURE USING A CONTRALATERAL APPROACH, THE SMART CONTROL STENT WAS FOUND TO BE DEPLOYED APPROXIMATELY 1 SEGMENT AT BEYOND THE CURVE PAR. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS AT DISTAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES EXPERIENCED IN PREPPING THE DEVICE. A NON-CORDIS SHEATH INTRODUCER WAS INSERTED AND A NON-CORDIS GUIDEWIRE WAS ADVANCED TO THE LESION AFTER PRE-DILATION. HOWEVER, THE GUIDEWIRE WAS UNABLE TO BE ADVANCED DUE TO THE HEAVY CALCIFICATION AT THE EXTERNAL ILIAC ARTERY. THE GUIDEWIRE WAS EXCHANGED FOR ANOTHER ONE AND RE-ADVANCED. WHEN IT WAS NOTICED THAT PART OF THE SMART CONTROL STENT WAS DEPLOYED, THE STENT WAS REMOVED FROM THE PATIENT¿S BODY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER IT WAS COMPLETED SUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6321787 ↗

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