Advance G52350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002523507), received between Sep 25, 2023 and Sep 25, 2023 — 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.

• MalfunctionSep 25, 2023Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED 03OCT2023. ANOTHER MANUFACTURER'S 6-FRENCH, 10-CENTIMETER INTRODUCER WAS USED DURING THE PROCEDURE, AS WELL AS AN UNSPECIFIED INFLATION DEVICE. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR STENOSED. THE BALLOON RUPTURED UPON THE FIRST INFLATION WITHIN A NON-OCCLUDED LESION IN THE RIGHT BRACHIAL ARTERY. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON CATHETER WAS REMOVED BY ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808300 ↗