Advance G50223Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502236), received between May 14, 2021 and May 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 16, 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.

• MalfunctionMay 14, 2021Material Rupture; Material Rupture

  ADDITIONAL INFORMATION RECEIVED ON 07JUN2021: THE BALLOON WAS REMOVED BY PULLING. A 5/6FR CORDIS SHEATH WAS UTILIZED. AN INFLATION DEVICE WAS USED. THE RUPTURE OCCURRED DURING THE FIRST INFLATION OF THE BALLOON, AND IT WAS INFLATED TO LESS THAN NOMINAL PRESSURE. THE BALLOON WAS NOT INFLATED INSIDE OF THE STENT PRIOR TO RUPTURE. THERE WAS NO NOTED TO BE SIGNIFICANT ANGULATION OR VIRTUOSITY AND LOCATION OF THE LESION WAS THE AT ORIGIN. THE VESSEL WAS NOTED TO BE MODERATELY/HEAVILY CALCIFIED. THERE WAS NO NOTED OCCLUSION. THE BALLOON MARKERS STARTED SEPARATING ON THE WIRE WHEN ATTEMPTING TO REMOVE. USING ROTATION AND TENSION, THE DEVICE WAS ABLE TO BE REMOVED. THE VESSEL OCCLUDED DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824587 ↗