Advance G50265Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502656), received between Sep 13, 2019 and Sep 13, 2019 — classified as 1 injury.

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.

• InjurySep 13, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING A PROCEDURE TO RE-DILATE AN EXISTING UNKNOWN STENT IN THE RIGHT PULMONARY ARTERY INVOLVING A MALE PEDIATRIC PATIENT OF UNSPECIFIED AGE, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND SEPARATED UPON REMOVAL. AN UNKNOWN 8 FRENCH SHEATH AND UNKNOWN WIRE GUIDE WERE UTILIZED DURING THE PROCEDURE. THE BALLOON WAS INFLATED ONCE INSIDE THE STENT TO 10 ATMOSPHERES WITH A 1:3 RATIO OF LOPAMIROL CONTRAST TO SALINE. THERE WAS NO REPORTED ANGULATION, TORTUOSITY, OR CALCIFICATION. THE BALLOON AND SHEATH WERE REMOVED AS A UNIT, OVER A WIRE GUIDE, WHILE PERFORMING A COUNTERCLOCKWISE ROTATION OF THE BALLOON. THERE WAS NO BLOOD OBSERVED INSIDE OF THE UNKNOWN INFLATION DEVICE. AN OPEN SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE BALLOON FROM THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 9030246 ↗