SaberX Radianz R51003004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032081815), received between Mar 11, 2024 and Mar 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Burst Container or Vessel

  AS REPORTED, THE 3MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED USING A NEW 4MM 4CM SABERX RADIANZ DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DIFFICULTY WAS ENCOUNTERED WHEN REMOVING IT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR ANY STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS TRI (TRANSRADIAL INTERVENTION) TARGETING THE ILIAC ARTERY. THE LESION WAS SEVERELY CALCIFIED WITH MODERATE VESSEL TORTUOSITY AND 90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION WAS EXPERIENCED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT PLACED IN AN ACUTE BEND, AND NO KINKING OCCURRED DURING USE. A 50:50 CONTRAST-TO-SALINE RATIO WAS USED. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483810 ↗
• MalfunctionMar 11, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER DELIVERING A 3MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO THE LESION, THE BALLOON RUPTURED DURING ITS INITIAL INFLATION TO 8 ATMOSPHERES (ATM). A NEW SABERX PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY (SFA), WITH MILD CALCIFICATION, MILD TORTUOSITY, AND 90% STENOSIS. 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 DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574742 ↗
• MalfunctionFeb 25, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 3MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS INITIAL INFLATION TO 8 ATMOSPHERES (ATM). THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS THE ILIAC. THE TARGET SITE VESSEL CHARACTERISTICS WERE MODERATE CALCIFICATION, MILD TORTUOSITY, AND 90% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS ABLE TO BE DELIVERED TO THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458095 ↗
• MalfunctionApr 30, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 3MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 8 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. A NEW UNKNOWN SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212169 ↗
• MalfunctionMar 11, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 4CM SABER PTA (RADIANZ) WAS USED FOR PRE-DILATION. HOWEVER, THE PRESSURE WAS UNABLE TO RISE OVER ITS NOMINAL PRESSURE. THE PHYSICIAN SUSPECTED THE COMPLAINT DEVICE RUPTURED. THEREFORE, THE COMPLAINT DEVICE WAS REMOVED, AND OTHER BALLOON CATHETER(S) (NON-CORDIS) WERE USED TO CONTINUE THE PROCEDURE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. AFTER THAT, THE PHYSICIAN CONFIRMED THAT FOUR OF BALLOON CATHETERS (NON-CORDIS) RUPTURED BUT THE LESION WAS GRADUALLY INFLATED, AND STENT(S) WERE IMPLANTED, AND THE PROCEDURE COMPLETED. THIS ISSUE MIGHT HAVE CAUSED BY SEVERE CALCIFICATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE ILIAC ARTERY. AN UNKNOWN GUIDEWIRE CROSSED THE LESION. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. THERE IS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE VESSEL WAS NOTED IT DID NOT HAVE ANY TORTUOSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876493 ↗