SaberX Radianz R51005025LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032081419), received between Jan 6, 2020 and Mar 18, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM X 25CM 155 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS USED FOR PRE-DILATATION HOWEVER, IT RUPTURED AT 8 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED BY REPLACING NEW NON-CORDIS BALLOON CATHETER AND IT COULD INFLATE AND IMPLANTED THE SABER. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD STENOSIS AND NO VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY BY MAINTAIN NEGATIVE PRESSURE. 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 NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE INDEFLATOR/SYRINGE USE WAS MOUNT FUJ, AAA (B)(6) LLC. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849537 ↗
• MalfunctionJan 6, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 25CM 155 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS DELIVERED TO THE LESION FOR PRE-DILATION, BUT IT RUPTURED AT TEN ATMOSPHERES (10 ATM) BELOW NOMINAL PRESSURE DURING ITS INITIAL 30 SECOND INFLATION. THEREFORE, IT WAS REPLACED WITH NEW ANOTHER NON-CORDIS BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS AT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND IT WAS NOTED WITH HEAVY CALCIFICATION AND HIGH PERCENTAGE OF STENOSIS. AN IPSILATERAL APPROACH WAS MADE USING A NON-CORDIS GUIDING SHEATH. THE GUIDEWIRE HAD CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554434 ↗