Advance G52259Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002522593), received between Jul 12, 2017 and Jul 27, 2017 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJul 27, 2017Material Rupture

  DURING PREPARATION FOR THE PROCEDURE THE BALLOON WAS RUPTURED DURING RINSING. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. NO ADVERSE EVENTS ARE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6748464 ↗
• MalfunctionJul 27, 2017Material Rupture

  THE BALLOON RUPTURED PRIOR TO NOMINAL PRESSURE INFLATION IN A HEAVILY CALCIFIED VESSEL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6748249 ↗
• InjuryJul 12, 2017Material Rupture

  WHILE BEING USED IN HEAVILY CALCIFIED ARTERIES, THE BALLOON RUPTURED DURING INFLATION. IT WAS NOTED THAT THE CALCIUM DEPOSITS TORE THE BALLOON. THE PATIENT WAS SENT FOR BYPASS AFTER THE UNSUCCESSFUL PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6706375 ↗