Advance G34359Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002343594), received between Jul 12, 2017 and Oct 3, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED 14JAN2020. ANOTHER MANUFACTURER'S 5 OR 6 FRENCH SHEATH WAS USED DURING THE PROCEDURE. AN UNKNOWN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON, USING A 50/50 SOLUTION OF OMNIPAQUE, WITHIN THE TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY/PROXIMAL POPLITEAL ARTERY. A SLOW LEAK WAS OBSERVED IMMEDIATELY UPON THE FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT, BY ITSELF, AND WAS THEN TESTED. ANGULATION AND TORTUOSITY WERE NOT REPORTED; HOWEVER, MINOR CALCIFICATION WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152806 ↗
• MalfunctionMay 1, 2019Material Puncture/Hole; Material Puncture/Hole

  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 8570723 ↗
• MalfunctionAug 29, 2017Inflation Problem; Inflation Problem

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, AT APPROXIMATELY 10 ATM, THE BALLOON WOULD NOT INFLATE INSIDE THE AFS CALCIFIED LESION. IT WAS FURTHER REPORTED, THE BALLOON MAY HAVE A HOLE IN MATERIAL AS IT SEEMED TO BE SCRATCHED WHEN GOING THROUGH THE CALCIFICATION. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 6828871 ↗
• MalfunctionJul 12, 2017Burst Container or Vessel; Leak/Splash

  WHEN INFLATING THE BALLOON IT LEAKED WITH LOW PRESSURE. DURING THE PROCEDURE THE BALLOON BURST BEFORE 10 BARS OF PRESSURE WAS REACHED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6706165 ↗