Advance G50248Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502489), received between Nov 13, 2018 and Nov 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• MalfunctionNov 13, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS OBSERVED TO BE LEAKING FROM A SMALL PUNCTURE DURING AN ANGIOPLASTY PROCEDURE AND PLACEMENT OF A STENT IN A RIGHT-ARM FISTULA. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAD A HISTORY OF A BLOCKED ARTERIOVENOUS (AV) FISTULA. DURING THE PROCEDURE, THE BALLOON DEVICE WAS ADVANCED OVER ANOTHER MANUFACTURER'S WIRE GUIDE, TO THE FISTULA BLOCKAGE. UPON INFLATION OF THE DEVICE, NOMINAL PRESSURE WAS NOT ABLE TO BE ACHIEVED. THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS REMOVED AND INFLATED AGAIN ON THE "SCRUB TROLLEY." THIS IS WHEN A SMALL PUNCTURE WAS NOTED IN THE BALLOON MATERIAL, AS FLUID LEAKED DURING THE ATTEMPTED INFLATION. IT WAS PROVIDED THAT ANOTHER BALLOON DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 8065542 ↗