SaberX Radianz R51008006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032081877), received between Mar 8, 2023 and Aug 19, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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.

• MalfunctionAug 19, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 8MM 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING POST-DILATATION OF THE 6X60MM SMART ILIAC STENT. THE BALLOON RUPTURED AT NOMINAL PRESSURE. ANOTHER PRODUCT 8-40MM SABERX WAS USED TO RE-DILATE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841580 ↗
• InjuryMar 8, 2023Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED, A PROCEDURE TO TREAT A 90% STENOSIS OF THE RIGHT COMMON ILIAC ARTERY (CIA) WAS PERFORMED VIA THE LEFT RADIAL ARTERY. A 5F NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS INSERTED VIA THE LEFT RADIAL ARTERY AND A NON-CORDIS .035 GUIDEWIRE WAS PLACED IN THE ABDOMINAL AORTA WITH AN UNKNOWN PIGTAIL CATHETER. THE 5F NON - CORDIS CSI WAS THEN EXCHANGED FOR A 110CM BRITE TIP RADIANZ CSI. A NON-CORDIS .018 FLOPPY GUIDEWIRE WAS PLACED ACROSS THE LESION AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-CORDIS IVUS CATHETER. NEXT, PRE-DILATION WAS PERFORMED WITH AN 8MM X 60MM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. A 10MM X 60MM SMART RADIANZ SELF-EXPANDING STENT (SES) WAS THEN INSERTED VIA THE LEFT RADIAL ARTERY AND WAS IMPLANTED. DURING IMPLANTATION, THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY AND THE STENT WAS FULLY OPPOSED TO THE VESSEL WALL WHEN DEPLOYED. AN IVUS WAS THEN ATTEMPTED WITH THE NON-CORDIS IVUS CATHETER; HOWEVER, THE IVUS CATHETER WAS CAUGHT ON THE PROXIMAL EDGE OF THE IMPLANTED SMART STENT CAUSING THE STENT MARKER EDGE TO BECOME UPLIFTED. THE NON-CORDIS IVUS CATHETER WAS THEN REMOVED AND THE 8MM X 6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503614 ↗