SaberX Radianz R51006006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032081549), received between May 26, 2023 and Apr 3, 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.

• MalfunctionApr 3, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 6MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 4 ATMOSPHERES (ATM). A 6MM X 4CM SABERX RADIANZ PTA BALLOON CATHETER WAS OPENED AND EXPANDED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). AN UNKNOWN GUIDEWIRE WAS INSERTED PRIOR TO USE OF THE 6MM SABERX RADIANZ PTA BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776356 ↗
• MalfunctionDec 11, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED. THE BALLOON RUPTURED AT ITS NOMINAL PRESSURE. ANOTHER BALLOON WAS USED TO MANAGE THE SITUATION AND THE PROCEDURE ENDED WITHOUT ISSUE. 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, THE PROTECTIVE BALLOON COVER, THE STYLET, OR OTHER STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGE WERE OBSERVED BEFORE INSERTION. THE DEVICE WAS PREPPED PER THE IFU AND MAINTAINED NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR THERAPY (EVT) TARGETING THE LEFT EXTERNAL ILIAC ARTERY. THE LESION HAD SEVERE CALCIFICATION, MODERATE VESSEL TORTUOSITY, AND 80% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE OR FRICTION NOTED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR GUIDE CATHETER. NO DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT PLACED IN AN ACUTE BEND AND DID NOT KINK DURING USE. THE DEVICE WILL NOT BE RETUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782357 ↗
• MalfunctionJul 18, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING NOMINAL PRESSURE. THERE WERE NO REPORTED INJURIES 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 22542003 ↗
• MalfunctionDec 22, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PRE-DILATION, BUT THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). AN UNKNOWN 5MM X 6CM BALLOON CATHETER WAS USED AS A REPLACEMENT TO PRE-DILATE THE LESION. ONE 8MMX 100MM SMART RADIANZ SES DELIVERY SYSTEM WAS IMPLANTED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSIS LEFT EXTERNAL ILIAC ARTERY LESION WHICH HAD MODERATE CALCIFICATION. THERE WAS NO VESSEL TORTUOSITY. A 6F NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS USED FOR ACCESS. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS PREPPED WITH A 2:1 SALINE TO CONTRAST RATIO. 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 18382648 ↗
• MalfunctionMay 26, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM 6CM SABERX RADIANZ PTA RUPTURED WITHIN ITS NOMINAL PRESSURE DUE TO SEVERE CALCIFICATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE ILIAC ARTERY WHICH HAD STENOSIS. 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 17011292 ↗