Advance G52374Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002523743), received between Apr 5, 2017 and Oct 17, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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

• InjuryOct 17, 2017Material Rupture; Material Separation; Material Rupture; Material Separation

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN ANGIOPLASTY PROCEDURE. IT WAS REPORTED THAT THE BALLOON BROKE/RUPTURED AT 8ATM, AT THE TIP, WHILE IN THE PATIENT AND A PIECE OF THE TIP SEPARATED FROM THE DEVICE. THEY TRIED TO RETRIEVE THE PIECE WITH A SNARE, BUT WERE UNSUCCESSFUL. A SMALL STENT WAS PLACED OVER THE FRAGMENT SO THAT IT WOULD NOT MIGRATE INTO THE LUNG. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6956715 ↗
• InjuryApr 5, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN AV FISTULA ANGIOPLASTY PROCEDURE USING AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, THE BALLOON FRAGMENTED IN THE RIGHT CEPHALIC VEIN DURING THE LAST INFLATION. IT WAS REPORTED THAT THE INFLATION PRESSURE WAS ABOVE THE NOMINAL PRESSURE RATE. CONTRAST USED WAS A 50/50 MIX ULTRAVIST 370. THERE WAS NO ANGULATION OR VESSEL CALCIFICATION NOTED. THE BALLOON WAS NOTED TO HAVE BURST CIRCUMFERENTIALLY. THE LARGEST FRAGMENT WAS RETRIEVED HOWEVER, A SMALLER PIECE THAT INCLUDED THE RADIOPAC SEGMENT MIGRATED INTO THE COLLATERAL VEIN OF THE RIGHT ARM BUT DID NOT POSE A HEMODYNAMIC PROBLEM. AN ATTEMPT WAS MADE TO RETRIEVE THE PIECE WITHOUT SUCCESS. IT WAS REPORTED THAT THE PATIENT IS ASYMPTOMATIC AND THE FISTULA (DIALYSIS) IS WORKING WITHOUT ANY COMPLICATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6461367 ↗