SaberX Radianz R51007006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032081457), received between Nov 2, 2023 and Apr 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 7MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846453 ↗
• MalfunctionApr 28, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT ABOUT 4 ATMOSPHERES (ATM) DUE TO CONTACT WITH A CALCIFIED AREA. A 7MM X 40MM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUDED (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED SEVERE CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS ABOUT 50%. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918390 ↗
• MalfunctionNov 2, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MM 6CM SABERX PTA (RADIANZ) WAS USED FOR THE ILIAC ARTERY. HOWEVER, THE DEVICE RUPTURED. 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, REMOVING THE PROTECTIVE BALLOON, 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 WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO HOLD NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE BALLOON CATH. THE CATHETER WAS NOTED TO HAVE BEEN IN AN ACUTE BEND. THE BALLOON CATHETER WAS NEVER KINKED WHILE BEING USED. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE USE OF A NON-CORDIS DEVICE. THIS WAS DURING AN EVT CASE. THE DEVICE WAS DISCARDED DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056589 ↗