SaberX Radianz R51010004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032086735), received between Aug 16, 2023 and Feb 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionFeb 28, 2024Difficult to Remove; Difficult to Remove

  AS REPORTED, A 10MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS STUCK ON AN IMPLANTED SMART SELF-EXPANDING STENT (SES) AND WAS UNABLE TO CROSS AN ILIAC ARTERY LESION. ADDITIONALLY, THERE WAS DIFFICULTY REMOVING THE DEVICE; HOWEVER, THE DEVICE WAS REMOVED SLOWLY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. A VASSALLO GUIDEWIRE WAS USED WITH THE SABERX RADIANZ PTA BALLOON CATHETER DURING THIS PROCEDURE AND THERE WAS NO RESISTANCE BETWEEN THE SABERX RADIAN PTA BALLOON CATHETER AND THE GUIDEWIRE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799376 ↗
• MalfunctionAug 16, 2023Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF AN 10MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST. WHEN TRYING TO REMOVE THE RADIANZ PTA, THE DEVICE WAS STUCK WITHIN A 110CM BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI). THE BRITE TIP RADIANZ CSI WAS REMOVED UNDER ASPIRATION AND THE RADIANZ PTA CAME OUT WITH THE CSI; HOWEVER, THE RADIANZ PTA BALLOON CATHETER DID NOT REMAIN IN ONE PIECE DURING ITS REMOVAL. A 10MM X 8CM SABERX RADIANZ PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN ILIAC LESION WHICH HAD SEVERE CALCIFICATION BUT SHOWED NO SIGNS OF TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON WAS PREPPED WITH A 60% CONTRAST AND 40% SALINE MIXTURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558026 ↗