SaberX Radianz R51006015LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032081914), received between Apr 8, 2023 and Jan 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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.

• MalfunctionJan 17, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM 15CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS USED. HOWEVER, IT RUPTURED AT 8ATM DURING ITS INITIAL INFLATION. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (6MM15CM, NON-CORDIS). THE PROCEDURE WAS COMPLETED WITH DCB. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH HAD STENOSIS. A CONTRALATERAL APPROACH WAS MADE WITH A 6FR NON-CORDIS SHEATH AND A .014 CROSS WIRE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181365 ↗
• MalfunctionApr 8, 2023Deflation Problem; Deflation Problem

  AS REPORTED, ALL THREE SABER X RADIANZ BALLOONS FAILED TO DEFLATE IN AN APPROPRIATE AMOUNT OF TIME. WITH ALL THREE BALLOONS IT TOOK 12 TO 15 SECONDS TO FULLY DEFLATE AND THE PHYSICIAN HAD TO PULL NEGATIVE THREE TIMES ON EVERY BALLOON, AFTER EVERY INFLATION, IN ORDER TO GET IT FULLY DEFLATED. ON COUPLE OF ATTEMPTS THE BALLOON DID NOT FULLY DEFLATE. ALSO, ONCE THE BALLOONS WERE REMOVED FROM THE BODY THEY COULD NOT BE REINSERTED AS THEY DID NOT EVER REWRAP. IT WAS FEARED THE LARGE, UNWRAPPED PROFILE OF THE USED BALLOON DISRUPT THE STENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705205 ↗