Advance G50236Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002502366), received between Sep 19, 2017 and Feb 18, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING ANGIOPLASTY AND STENTING OF THE ILIAC ARTERIES AT THE AORTIC BIFURCATION, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND SEPARATED UPON THE FIRST INFLATION. THE ANATOMY WAS REPORTED TO BE VERY SEVERELY CALCIFIED WITH ANGULATION OVER THE AORTIC BIFURCATION, WHERE THE 100% OCCLUDED LESION WAS LOCATED. AN UNKNOWN 6 FRENCH SHEATH WAS UTILIZED DURING THE PROCEDURE. AN UNKNOWN INFLATION DEVICE AND A 50:50 RATIO OF OMNIPAQUE 300 SOLUTION WERE USED TO INFLATE THE BALLOON, WHICH RUPTURED AT ELEVEN ATMOSPHERES. A THREE-CENTIMETER PORTION OF THE BALLOON THEN SEPARATED FROM THE SHAFT. THE BALLOON CATHETER WAS REMOVED OVER AN UNKNOWN WIRE GUIDE, MAINTAINING NEGATIVE PRESSURE AFTER ALLOWING THE DEVICE TO RETURN TO AMBIENT PRESSURE, UTILIZING A COUNTERCLOCKWISE ROTATION. THE USER ATTEMPTED TO REMOVE THE SEPARATED PORTION OF THE BALLOON FROM THE ILIAC ARTERY; HOWEVER, THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN SUCCESSFULLY STENTED THE SEPARATED PORTION OF THE BALLOON AGAINST THE VESSEL WALL, USING AN UNKNOWN STENT. THE BALLOON WAS NOT INFLATED WITHIN A STENT PRIOR TO RUPTURE. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. ACCORDING

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9721203 ↗
• MalfunctionSep 19, 2017Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material

  AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN UNSPECIFIED PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED, DURING INFLATION, CONTRAST LEAKED FROM THE TIP OF THE BALLOON. THE BALLOON LEAK, WHICH THE PHYSICIAN BELIEVES TO BE A PINHOLE, WAS NOTICED PRIOR TO INFLATION AT NOMINAL PRESSURE. 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 Known Impact Or Consequence To Patient

  MAUDE report 6875839 ↗