SaberX Radianz R51009004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032086766), received between Jul 24, 2025 and Nov 4, 2025 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 9MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM) DURING DILATION OF THE LESION. AN 8MM X 40MM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ILIAC ARTERY PROCEDURE. THE TARGET VESSEL WAS SEVERELY CALCIFIED, MODERATELY TORTUOUS, AND HAD A STENOSIS OF 90%. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND DURING THE PROCEDURE, WAS ABLE TO CROSS THE LESION, DID NOT KINK, AND WAS REMOVED EASILY AND INTACT FROM THE PATIENT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464595 ↗
• DeathJul 25, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER PLACING A SMART RADIANZ (UNKNOWN SIZE), POST-DILATION WAS PERFORMED USING A 9X40 SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THERE WAS NO ISSUE OR MALFUNCTION WITH THE SMART STENT THAT WAS IMPLANTED. WITH A RATED BURST PRESSURE (RBP) OF 10 ATM, THE TRAINEE DOCTOR MISTAKENLY APPLIED 20 ATM. THE BALLOON RUPTURED AND THE VESSEL ALSO RUPTURED. THE BLOOD PRESSURE DROPPED. A NON-CORDIS COVERED STENT WAS PLACED FOR HEMOSTASIS. HOWEVER, THE PATIENT DIED THE NEXT DAY. THE PATIENT WAS UNDERGOING A TRANS-RADIAL INTERVENTION (TRI) OF THE ILIAC ARTERY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). 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. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE LESION WAS MINIMALLY CALCIFIED. THE VESSEL TORTUOSITY WAS MODERATE. THE PERCENTAGE OF STENOSIS WAS 90%. THE CATHETER WAS NEVER IN AN ACUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610717 ↗
• MalfunctionJul 24, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 9MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS FIRST INFLATION TO 6 ATMOSPHERES (ATM) AFTER BEING DELIVERED TO THE LESION. AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS THE ILIAC ARTERY, WHICH EXHIBITED MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588816 ↗