S.M.A.R.T. RADIANZ SR07100XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032082508), received between May 27, 2025 and Jan 9, 2026 — classified as 2 malfunctions.

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.

• MalfunctionJan 9, 2026Difficult or Delayed Positioning

  AS REPORTED, THE STENT OF A 7MM X 100MM S.M.A.R.T. RADIANZ VASCULAR STENT SYSTEM DID NOT DEPLOY WHEN THE THUMB WHEEL WAS ROTATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR A RIGHT EXTERNAL ILIAC ARTERY CHRONIC TOTAL OCCLUSION CASE VIA A RIGHT RADIAL ARTERY APPROACH. AFTER GUIDEWIRE PASSAGE, PRE-DILATION WAS PERFORMED, AND STENT DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE THUMB WHEEL BECAME STIFF AND COULD NOT BE MOVED. DURING WITHDRAWAL OF THE DEVICE, STENT DEPLOYMENT BEGAN UNINTENTIONALLY, RESULTING IN DEPLOYMENT IN A PULLED-BACK STATE PROXIMAL TO THE TARGET LESION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021849 ↗
• MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DELIVERY SYSTEM AND STENT OF A 7MM X 100MM 190CM S.M.A.R.T. RADIANZ VASCULAR STENT SYSTEM BROKE APART WHILE THE OPERATOR USED IT ON THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING. THE DEVICE WAS OPENED IN A STERILE FIELD. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088679 ↗

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