S.M.A.R.T. RADIANZ SR08100XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032082393), received between Aug 3, 2023 and Apr 29, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER IMPLANTATION OF AN 8MM X 100MM SMART RADIANZ SELF-EXPANDING STENT (SES), WHEN REMOVING THE DELIVERY SYSTEM FROM THE PATIENT OVER A 300CM VASSALLO FLOPPY GUIDEWIRE, IT WAS NOTICED THAT THE FRONT END WAS TORN OFF. THE 10CM SEPARATED SEGMENT REMAINED ON THE VASSALLO GUIDEWIRE AND WAS ABLE TO BE REMOVED WITHOUT ISSUE BY PULLING THE GUIDEWIRE. ADDITIONALLY, THERE WAS SOME RESISTANCE WHEN REMOVING THE DELIVERY SYSTEM DUE TO RESISTANCE WITH THE GUIDEWIRE. THE PROCEDURE CONTINUED BY IMPLANTING A 7MM X 60MM SMART VASCULAR SES AT THE EXTERNAL ILIAC ARTERY (EIA). THE RIGHT COMMON ILIAC ARTERY WAS THEN TREATED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT TWO SEPARATE LESIONS, ONE IN THE LEFT COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY (EIA), AND ONE IN THE RIGHT COMMON ILIAC ARTERY TO SUPERFICIAL FEMORAL ARTERY (SFA). THE EIA LESION HAD A STENOSIS OF 85% - 95% AND WAS MODERATELY CALCIFIED. THE SFA LESION HAD A STENOSIS OF 90%-100% AND WAS MODERATELY CALCIFIED. A 6F 90CM NON-CORDIS GUIDING SHEATH WAS USED FOR ACCESS FROM THE LEFT BRACHIAL ARTERY TO THE LEFT ILIAC ARTERY. VARIOUS UNKNOWN GUIDEWIRES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201032 ↗
• MalfunctionDec 7, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, WHEN USING AN 8MM X 100MM SMART RADIANZ SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE STENT EDGE COULD BE DEPLOYED BUT THE STENT COULD NOT BE DEPLOYED. THE DEVICE WAS REPLACED WITH A NEW, UNKNOWN SMART CONTROL SES TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN ILIAC LESION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18286177 ↗
• MalfunctionAug 3, 2023Defective Component; Defective Component

  AS REPORTED A SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WAS USED BUT RUPTURED DUE TO SEVERE CALCIFICATION. ADDITIONALLY, A 6F SMART RADIANZ VASCULAR STENT WAS USED BUT THE STENT LENGTH WAS LONGER THAN EXPECTED. THE COMPLAINT DEVICES WERE REPLACED WITH TWO DIFFERENT SABERX RADIANZ AND SMART RADIANZ DEVICES OF DIFFERENT SIZES AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE BEING USED IN AN ENDOVASCULAR THERAPY (EVT) PROCEDURE. THE LENGTH OF THE LESION WAS ABOUT 8CM. THERE WAS SEVERE VESSEL TORTUOSITY WITH ONE-HUNDRED PERCENT (100%) STENOSIS. THERE WERE NO ISSUES EXPERIENCED WITH THE GUIDING SHEATH. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER NOR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON INTO THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451859 ↗

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