Advance G52339Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002523392), received between Feb 22, 2018 and May 30, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2019Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8654035 ↗
• MalfunctionMar 13, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF AN ABDOMEN WITH RUNOFF PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER SNAPPED IN TWO UPON REMOVAL OF THE BALLOON FROM THE PATIENT. A PORTION OF THE CATHETER REMAINED WITHIN THE PATIENT'S ANATOMY AND WAS ABLE TO BE PULLED OUT. A WIRE GUIDE (MANUFACTURER UNSPECIFIED) WAS IN PLACE UPON REMOVAL OF THE CATHETER; ANOTHER MANUFACTURER'S 6 FRENCH (FR) SHEATH WAS UTILIZED DURING THE PROCEDURE. THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE ONCE DEFLATED. THE LESION WAS LOCATED IN THE PATIENT'S COMMON FEMORAL ARTERY; ANGULATION AND CALCIFICATION WERE PRESENT. 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 7334004 ↗
• MalfunctionFeb 22, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING VISUAL INSPECTION PRIOR TO USE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS OBSERVED TO BE PERFORATED BY THE PHYSICIAN. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7290168 ↗