Saber .035 48009004NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032080399), received between Dec 9, 2022 and Dec 9, 2022 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE SABER .035 9MM 4CM BURST AFTER THE PHYSICIAN INFLATED THE BALLOON FOR A FEW SECONDS. THE PHYSICIAN COULD FEEL IT LOSE PRESSURE. THE BALLOON WAS REMOVED FROM THE BODY WITHOUT INCIDENT. THE BALLOON APPEARED TO BE INTACT. IT WAS THAN INFLATED WITH A 10CC SYRINGE, THE DISTAL PART (BY THE TIP) OF THE BALLOON LEAKED. THE PATIENT WAS NOT HARMED, ANOTHER BALLOON (NOT CORDIS) WAS USED TO FINISH THE PROCEDURE AND THE PATIENT WENT TO THE RECOVERY ROOM WHERE THEY WERE DISCHARGED TO HOME WITHOUT FURTHER INCIDENT. THIS WAS A FISTULOGRAM PATENCY CHECK, POSSIBLE INTERVENTION. THE PHYSICIAN DOES NOT USE AN INDEFLATOR SO THE EXACT ATM USED IS UNKNOWN. NO ISSUES WITH PREP OR INSERTION OF DEVICE. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955706 ↗