SaberX Radianz R51004004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20705032081761), received between Mar 23, 2020 and Feb 9, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Burst Container or Vessel

  AS REPORTED, THE 4MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED FOR SEVERE CALCIFIED STENOSIS OF THE SUPERFICIAL FEMORAL ARTERY. DURING THE SECOND DILATION, THE BALLOON RUPTURED AT ABOUT 5 ATM, WHICH DID NOT REACH THE SPECIFIED PRESSURE. 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 24292848 ↗
• MalfunctionAug 21, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS BEING USED DURING "PRE-STAGE". THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860766 ↗
• MalfunctionJul 9, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS USED, BUT THE BALLOON RUPTURED AT NOMINAL PRESSURE. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DR. USED A LEFT BRACHIAL APPROACH. AN UNKNOWN GUIDEWIRE PASSED THROUGH THE POPLITEAL CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461434 ↗
• MalfunctionJan 13, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4X40 SABER RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT THE LESION. A NEW NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. IT IS BELIEVED THAT THE BALLOON HIT A CALCIFIED LESION. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. 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. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY (I.E MAINTAIN NEGATIVE PRESSURE). THE INTENDED TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS SEVERELY CALCIFIED, MODERATELY TORTUOUS AND WAS A CHRONIC TOTAL OCCLUSION (CTO) WITH A STENOSIS OF 100%. THE BALLOON BURST/RUPTURE AT 10 ATMOSPHERES (ATM). THE BALLOON RUPTURE DID NOT OCCUR WHILE IN A STENT. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137924 ↗
• MalfunctionOct 21, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION. A 6F 110CM BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI) WAS USED FOR THIS PROCEDURE AS WELL AS A VASSALLO GUIDEWIRE. 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 20494290 ↗
• MalfunctionApr 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 4MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING A PRE-DILATION INFLATION TO NOMINAL PRESSURE. THE DEVICE WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS RADIAL INTERVENTIONAL (TRI) PROCEDURE TO TREAT A 90% STENOSED EXTERNAL ILIAC ARTERY LESION WHICH HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED, HANDLED, 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. A VASSALLO FLOPPY GUIDEWIRE WAS USED AND WAS ABLE TO CROSS THE LESION. THERE WERE NO ISSUES REMOVING THE SABERX RADIANZ PTA BALLOON CATHETER WHICH WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096249 ↗
• MalfunctionOct 10, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 4MM 4CM SABERX RADIANZ WAS USED FOR PRE-DILATION BUT IT RUPTURED AT NOMINAL PRESSURE DURING THE SECOND INFLATION. THE SABERX DEVICE WAS REPLACED WITH ANOTHER NON-CORDIS BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. USING A NON-CORDIS GUIDE WAS INSERTED FROM THE LEFT RADIAL ARTERY. THE PHYSICIAN PASSED THE RIGHT ILIAC LESION WITH A VASSALLO FLOPPY AND A NON-CORDIS MICROCATHETER. ONE 8X80 SMART STENT WAS PLACES IN THE RIGHT ILIAC ARTERY. POST DILATION WAS DONE WITH A 6X60 SABERX RADIANZ BALLOON AND GOOD FLOW WAS CONFIRMED. THE LEFT ILIAC USED THE SAME PRE AND POST DILATION BALLOONS. TWO SMART STENTS WERE PLACED (8X40 AND 9X40) AND COMPLETED WITHOUT ANY PROBLEMS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907166 ↗
• MalfunctionAug 4, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MMX4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WAS UNABLE TO CROSS THE LESION. ANOTHER SABERX RADIANZ (4MM X4CM) PTA DILATION CATHETER WAS USED BUT RUPTURED. THE LESION WAS INFLATED BY USING ANOTHER SABERX RADIANZ OF A DIFFERENT SIZE. ADDITIONALLY, TWO SMART RADIANZ STENTS WERE IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED FOR TREATMENT OF BILATERAL ILIAC ARTERIES; AN APPROACH WAS MADE FROM THE RADIAL REGION. THERE WAS SEVERE LESION CALCIFICATION; MODERATE VESSEL TORTUOSITY AND ONE-HUNDRED PERCENT (100%) STENOSIS. PRODUCT STORAGE INFORMATION AND LENGTH OF STORAGE IS UNKNOWN. THE DEVICES WERE BROUGHT TO THE CATH LAB JUST BEFORE THE PROCEDURE. THE DEVICES WERE STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). BOTH DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE SECOND DEVICE WAS INFLATED AT FIFTEEN (15) ATMOSPHERES WHEN IT BURST. THERE WERE NO DEVICE ANOMALIES NOTED WHEN THE PRODUCTS WERE TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGING OR REMOVING THE PRODUCTS FROM THE HOOP NOR REMOVING THE PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463691 ↗
• MalfunctionJul 28, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER X RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS USED BUT RUPTURED AT THE CALCIFIED LESION. A NON-CORDIS DEVICE WAS USED AS REPLACEMENT AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON BURST DURING INITIAL INFLATION AT APPROXIMATELY 16 ATMOSPHERES (ATM). THERE WAS SEVERE VESSEL CALCIFICATION, MILD VESSEL TORTUOSITY AND ONE-HUNDRED PER CENT (100%) STENOSIS. THE DEVICE WAS BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO) GREATER THAN THREE (3) MONTHS. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO 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 DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY 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. SOME RESISTANCE/FRICTION WAS FELT WHILE INSERTING THE BALLOON INTO THE PATIENT. THE BALLOON CATHETER WAS NEVER IN ACUTE BEND AND DID NOT KINK WHILE BEING USED. THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415973 ↗
• MalfunctionMar 23, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM 4CM SABER RAPID EXCHANGE (RX) 155 BALLOON CATHETER (BC) WAS INSERTED INTO THE PATIENT, HOWEVER, IT RUPTURED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS SEVERELY CALCIFIED. THERE WAS MODERATE VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS AT 90%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS STORED, PREPPED NORMALLY AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). 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 DIFFICULTY CROSSING THE LESION. THE PRODUCTS WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. ANOTHER SABER BALLOON WAS NOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866275 ↗