S.M.A.R.T. RADIANZ SR06100XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032082386), received between Sep 19, 2022 and Sep 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Stretched” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, THE STENT DELIVERY SYSTEM OF THE S.M.A.R.T. RADIANZ 6X100MM WAS STUCK TO THE GUIDEWIRE WHILE TRYING TO REMOVE THE SYSTEM AFTER STENT DEPLOYMENT. IT WAS NOTED THAT THE WIRE REMAINED IN THE VESSEL AS THE DEVICE WAS REMOVED FROM THE PATIENT OVER THE WIRE. AFTER REMOVAL, IT WAS NOTED THE DEVICE DID NOT LOOK RIGHT AND IT LOOKED SEPARATED OR STRETCHED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO THE INSERTION INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY WITH NO DIFFICULTY. THE INTENDED LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY WHICH WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL DID NOT HAVE ANY TORTUOSITY. A NON-CORDIS WIRE WAS USED WITH THE SMART DEVICE. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE DEVICE THROUGH THE VESSEL. THE DEVICE CROSSED THE LESION WITHOUT DIFFICULTY. THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NEVER KINKED DURING USE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15452453 ↗

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