SaberX Radianz R51007004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20705032081808), received between Dec 20, 2019 and Aug 7, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Deflation Problem

  As reported, a 7mm X 4cm 190 cm SABERX RADIANZ percutaneous transluminal angioplasty (PTA) balloon catheter was unable to deflate after inflation in the body despite the application of negative pressure. Pressure could still be applied while the balloon remained inflated. Negative pressure was continuously applied, and after the pressure dropped slightly, the device was pulled back to the aorta and intentionally ruptured using the back end of the guidewire to complete the procedure. There was no reported patient injury. There was no problem during device preparation. There was no difficulty removing the protective balloon cover or any sterile packaging components, and a contralateral approach was not used. The device was used during PCPS removal. The target vessel was the femoral vein. At the target site, the vessel characteristics included no calcification, moderate tortuosity, 50% stenosis, a moderate acute angle, and moderate bifurcation. The vessel characteristics for accessing the target site included no calcification, no tortuosity, no stenosis, no acute angle, and moderate bifurcation. The device was not placed into an acute bend at any point during the procedure, successful

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50172334 ↗
• MalfunctionApr 6, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 7MM X 4CM SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT NOMINAL PRESSURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS BEING USED FOR PRE-DILATION OF AN EXTERNAL ILIAC ARTERY (EIA) STENOTIC LESION. 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 24790332 ↗
• MalfunctionJan 5, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES (ATM). A NON-CORDIS 7 X 4 BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE POST-DILATION. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT THE EXTERNAL ILIAC ARTERY (EIA) IN WHICH AN UNKNOWN SMART STENT WAS PLACED. 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 23955913 ↗
• MalfunctionJun 4, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, ONE CORDIS 8MM 4CM SABER RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ONE 7MM 4CM SABER RADIANZ PTA BALLOON POPPED DURING AN ANGIOGRAM PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143943 ↗
• MalfunctionNov 11, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MM4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 10ATM DURING POST-DILATION. THIS OCCURRED AFTER A SMART STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED USING A NON-CORDIS DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO DIFFICULTIES ENCOUNTERED WHEN REMOVING IT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET AND 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, MAINTAINING NEGATIVE PRESSURE DURING PREPARATION. THE INTENDED PROCEDURE WAS FOR THE EXTERNAL ILIAC ARTERY (EIA), AND THE LESION WAS NOT CALCIFIED, EXHIBITING MILD VESSEL TORTUOSITY AND 75% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE OR FRICTION WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, AND THERE WERE NO DIFFICULTIES IN ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THROUGH THE STENT. HOWEVER, THE CATHETER WAS IN AN ACUTE BEND AT ONE POINT. THE BALLOON CATHETER DID NOT K

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657936 ↗
• MalfunctionSep 23, 2024Leak/Splash; Leak/Splash

  AS REPORTED, WHEN USING A 7MM X 4CM SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE PRESSURE WAS RELEASED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287351 ↗
• MalfunctionJun 14, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT NOMINAL PRESSURE. A NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 MILD 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 19539522 ↗
• MalfunctionMay 22, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 8 ATMOSPHERES (ATM). AN UNKNOWN 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 75 % STENOSED ILIAC LESION WHICH HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. A VASSALLO GUIDEWIRE WAS USED DURING THE PROCEDURE. 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 MAINTAINED 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 19376580 ↗
• MalfunctionApr 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT NOMINAL PRESSURE DURING A POST-DILATION INFLATION. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE LESION WAS REPORTED AS ¿HARD¿. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095833 ↗
• MalfunctionSep 12, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MM 4CM SABERX RADIANZ WAS USED FOR ADDING DILATION BUT RUPTURED AROUND ITS NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE ILIAC ARTERY WHICH HAD CTO. POBA WAS PERFORMED WITH A SMALL DIAMETER BALLOON CATHETER. 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 17728594 ↗
• MalfunctionJul 27, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED A SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WAS USED BUT RUPTURED DUE TO SEVERE CALCIFICATION. ADDITIONALLY, A 6F SMART RADIANZ VASCULAR STENT WAS USED BUT THE STENT LENGTH WAS LONGER THAN EXPECTED. THE STENT WAS REMOVED FROM THE PATIENT. ADDITIONAL STENTS WERE NEEDED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICES WERE REPLACED WITH TWO DIFFERENT SABERX RADIANZ AND SMART RADIANZ DEVICES OF DIFFERENT SIZES AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCTS WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICES WERE BEING USED IN AN ENDOVASCULAR THERAPY (EVT) PROCEDURE. THE LENGTH OF THE LESION WAS ABOUT 8CM. THERE WAS SEVERE VESSEL TORTUOSITY WITH ONE-HUNDRED PERCENT (100%) STENOSIS. THERE WERE NO ISSUES EXPERIENCED WITH THE GUIDING SHEATH. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17407562 ↗
• MalfunctionMar 17, 2020Burst Container or Vessel; Burst Container or Vessel

  A 7MM X 4CM X 155CM SABER RX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED FOR POST-DILATION OF A STENT HOWEVER THERE WAS LEAKAGE NOTED FROM THE BALLOON CATHETER. THE BALLOON DID NOT MAINTAIN PRESSURE DURING THE INFLATION BECAUSE IT RUPTURED WITH A MAXIMUM INFLATION PRESSURE OF 6 ATMOSPHERES (ATM). THEREFORE, THE BALLOON CATHETER WAS REMOVED EASILY INTACT IN ONE PIECE FROM THE PATIENT AND WAS REPLACED WITH A NEW UNKNOWN 6MM BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS ENDOVASCULAR THERAPY (EVT). THE TARGET LESION WAS THE EXTERNAL ILIAC ARTERY (EIA). THE LESION HAD MODERATE CALCIFICATION, NO VESSEL TORTUOSITY AND 100% OF STENOSIS. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS STORED PER 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. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREP NORM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843516 ↗
• MalfunctionDec 20, 2019Burst Container or Vessel; Burst Container or Vessel

  A 7MM 4CM 155 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT NOMINAL PRESSURE AFTER SEVEN SECONDS, DURING POST-DILATATION OF AN UNKNOWN STENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE SABER WAS THEREFORE REMOVED FROM THE PATIENT AND REPLACED WITH A NEW BALLOON CATHETER, TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. A CONTRALATERAL APPROACH WAS INITIALLY MADE, AND A STENT WAS IMPLANTED. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED DUE TO SUSPICION OF INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504038 ↗