Advance G52356Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002523569), received between Jan 28, 2019 and Jan 28, 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.

• InjuryJan 28, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING A BILATERAL ILIAC ANGIOPLASTY PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON WAS ADVANCED FROM THE ILIAC ARTERY INTO A HEAVILY CALCIFIED AORTA. IT WAS REPORTED THAT THE BALLOON WAS "SLIGHTLY LONG FOR THE CASE", WITH A PORTION OF THE BALLOON EXTENDING INTO THE AORTA. THE BALLOON ALLEGEDLY DID NOT REACH FULL PRESSURE PRIOR TO RUPTURE. THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON THROUGH AN UNKNOWN 6FR SHORT SHEATH UNSUCCESSFULLY. THE TIP WAS REPORTED TO REMAIN ON THE BALLOON, WHILE THE REMAINING PORTION OF THE DEVICE WAS HANGING FROM A PIECE OF THE CATHETER. IT WAS REPORTED THAT THE PATIENT REQUIRED A SURGICAL CUT-DOWN PROCEDURE TO REMOVE THE BALLOON AND PATCH REPAIR THE ARTERY. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8283008 ↗