SaberX Radianz R51005006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032081242), received between Dec 26, 2019 and Mar 6, 2025 — classified as 2 malfunctions.

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.

• MalfunctionMar 6, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA), THE 5MM 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED. THE BALLOON RUPTURED WITHIN NOMINAL PRESSURE. THE PROCEDURE WAS CONTINUED USING A DIFFERENT SIZE SABERX RADIANZ. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE INTENDED PROCEDURE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA), WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). THE LESION HAD SEVERE CALCIFICATION, MODERATE VESSEL TORTUOSITY, AND 100% STENOSIS. THERE WAS NO RESISTANCE OR FRICTION DURING INSERTION THROUGH THE ROTATING HEMOSTATIC VALVE OR GUIDE CATHETER. THERE WERE NO DIFFICULTIES ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR WHILE CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND AND DID NOT KINK DURING USE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540462 ↗
• MalfunctionDec 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 6CM 155 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED BUT RUPTURED AT APPROXIMATELY FIVE (5) ATMOSPHERES (ATM)WHICH IS WITHIN NOMINAL PRESSURE. THEREFORE, THE DEVICE WAS REPLACED WITH A NON-CORDIS BALLOON AND THE PROCEDURE WAS COMPLETED WITH DRUG COATED BALLOON (DCB). THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO). A NON-CORDIS GUIDEWIRE WAS USED TO CROSS THE LESION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9522278 ↗