Advance G50231Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502311), received between Jun 11, 2018 and Jun 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionJun 11, 2018Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE BALLOON WAS INTRODUCED OVER THE WIRE, A PART OF THE TIP WAS DISLOCATED FROM THE REST OF THE CATHETER. THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT AND ANOTHER PRODUCT WAS USED TO THE COMPLETE THE PROCEDURE. IT WAS ALSO LATER NOTED THAT THE BLUE TIP WAS SEPARATED ON THE WIRE GUIDE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7588076 ↗