SaberX Radianz R51005015LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032081433), received between Feb 27, 2023 and Jan 9, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Material Rupture

  AS REPORTED, AFTER PASSAGE OF AN UNKNOWN GUIDEWIRE, THE BALLOON ON A 5MM X 15CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) 190CM BALLOON CATHETER RUPTURED DURING THE FIRST DILATION AT ABOUT 8 ATMOSPHERES (ATM). THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS USED TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) LESION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027114 ↗
• MalfunctionOct 31, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 15CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. A NEW 5MM X 15CM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. 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 20577487 ↗
• 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 16705206 ↗
• MalfunctionFeb 27, 2023Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED, THE BALLOON OF A 5F 5MM X 15CM 190CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS NOT ABLE TO BE REMOVED ONCE THE BALLOON WAS DEFLATED AFTER THE FIRST INFLATION. A SUBSEQUENT INFLATION AND DEFLATION WERE DONE TO ENSURE THE BALLOON WAS FULLY DEFLATED. HOWEVER, THE BALLOON WAS STILL NOT ABLE TO BE REMOVED FROM THE NON-CORDIS SHEATH OVER THE WIRE. EVENTUALLY AFTER BACKING UP THE ENTIRE SYSTEM AS ONE, THE BALLOON RUPTURED AND WITH SOME FORCE IT WAS REMOVED FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY. IT BECAME OBVIOUS THE BALLOON HAD RUPTURED WHILE THE DOCTOR WAS STRUGGLING TO REMOVE THE BALLOON CATHETER WHILE THE DEVICE WAS BEING HELD AT NEGATIVE PRESSURE TO FACILITATE REMOVAL. THE BALLOON CATHETER WAS NOT ABLE TO BE EASILY REMOVED. THE DEVICE WAS NOT INFLATED WHEN IT WAS NOTICED THAT THE BALLOON HAD RUPTURED. THE BALLOON CATHETER WAS PULLED BACK ALL TOGETHER WITH THE WIRE AND SHEATH INSTEAD OF BEING PULLED BACK ALONE OVER THE WIRE. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT; HOWEVER, IT WAS BADLY DAMAGED IN THE PROCESS. THE USER WAS TRAINED TO THE DEVICE. THE PRODUCT WAS PROPERLY STORED AND OPENED IN STERIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448540 ↗