SaberX Radianz R51006004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032081754), received between Oct 2, 2023 and Apr 8, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Burst Container or Vessel

  AS REPORTED, A 6 MM X 40 MM SABER X-RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 10 ATM DURING PRE-DILATATION IN A TRANSRADIAL INTERVENTION (TRI) ILIAC CASE. A NEW DEVICE OF THE SAME SIZE WAS OPENED AND USED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR PRE-DILATATION IN AN ILIAC CASE VIA TRI APPROACH. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE. NO DEVICE DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING OR REMOVING THE PROTECTIVE BALLOON COVER. AN IPSILATERAL APPROACH WAS USED. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. NO ANOMALIES WERE NOTED AFTER THE DEVICE WAS DELIVERED TO THE LESION. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND WAS REMOVED INTACT IN ONE PIECE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. NO ANOMALIES WERE NOTED DURING INFLATION WITH POSITIVE PRESSURE. THERE WAS NO ANOMALY PREVENTING DEVICE INFLATION. THE INDEFLATOR GAUGE DID NOT INDICATE A LOSS OF PRESSURE. THE DEVICE WAS DISCARDED AT SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817977 ↗
• MalfunctionJan 21, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABERX RADIANZ 6MM4CM 190 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) RUPTURED DURING INFLATION AT THE LESION SITE. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS REPORTED TO HAVE BEEN STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION, AND THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE INTENDED PROCEDURE INVOLVED THE ILIAC ARTERY WITH A LEFT EXTERNAL ILIAC ARTERY TARGET, WHERE THE VESSEL EXHIBITED SEVERE CALCIFICATION, MODERATE TORTUOSITY, 100% STENOSIS, A MODERATE ACUTE ANGLE, AND MODERATE BIFURCATION. ACCESS VESSEL CHARACTERISTICS INCLUDED MODERATE TORTUOSITY, A MODERATE ACUTE ANGLE, AND MODERATE BIFURCATION. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION, AND THE BALLOON RUPTURED AT APPROXIMATELY 6 ATMOSPHERES. THE RUPTURE DID NOT OCCUR WITHIN A STENT. IOPAMIRON CONTRAST MEDIA WAS USED AT A HALF CONTRAST-TO-SALINE RATIO. THE SAME INDEFLATOR HAD BEEN USED SUCCESSFULLY W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132347 ↗
• MalfunctionAug 28, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MMX 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 4 ATMOSPHERES (ATM). AN UNKNOWN DEVICE WAS SUCCESSFULLY USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) PRE-DILATION. 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 22911823 ↗
• MalfunctionApr 28, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN PASSING THE LESION, THE 6MM 4CM SABER RADIANZ BALLOON RUPTURED. A BALLOON OF ANOTHER SIZE WAS USED TO CONTINUE THE PROCEDURE. THE BALLOON RUPTURED BELOW RBP. 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. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE 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 PER THE IFU. THE DEVICE PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS FOR AN ILIAC LESION. THE LESION WAS SEVERELY CALCIFIED. THE VESSEL TORTUOSITY WAS MODERATE. THE PERCENTAGE OF STENOSIS WAS 100%. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS A LITTLE DIFFICU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919872 ↗
• MalfunctionSep 30, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES (ATM). A NEW SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A COMMON ILIAC ARTERY WHICH HAD SEVERE CALCIFICATION. A TRANS-RADIAL APPROACH WAS USED. AN UNKNOWN GUIDEWIRE WAS CROSSED THE LESION PRIOR TO THE USE OF THE SABERX PTA BALLOON CATHETER. 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 20333224 ↗
• MalfunctionAug 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS INITIAL INFLATION. A NEW SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT AND A SMART RADIANZ SELF-EXPANDING STENT (SES) WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) PROCEDURE TO TREAT A 90% STENOSED ILIAC LESION WHICH HAD MILD CALCIFICATION AND MILD TORTUOSITY. AN APPROACH WAS MADE FROM THE LEFT RADIAL ARTERY WITH A BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI). A VASSALLO FLOPPY 18 GUIDEWIRE WAS USED TO CROSS THE LESION AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED PRIOR TO THE USE OF THE SABERX RADIANZ PTA BALLOON CATHETER. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962385 ↗
• MalfunctionOct 2, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER X RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER CROSSED THE LESION BUT RUPTURED DURING ITS INITIAL INFLATION AT EIGHT ATMOSPHERES (8 ATM). THE COMPLAINT DEVICE WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. VESSEL CALCIFICATION WAS MODERATE WITH MILD VESSEL TORTUOSITY, NO STENOSIS AND NINETY-PER CENT (90%) TOTAL OCCLUSION. THE DEVICE WAS STORED, HANDLED, AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). 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. THE CATHETER WAS NEVER IN AN ACUTE BEND AND THE THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WAS DISCARDED; THEREFOR, IT WILL NOT BE RETURNED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851224 ↗