Advance G52265Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002522654), received between Dec 22, 2016 and Apr 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19097496 ↗
• MalfunctionMay 17, 2022Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S STERILE PACKAGE WAS FOUND TO BE UNSEALED ON ONE SIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427009 ↗
• MalfunctionApr 18, 2022Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AS REPORTED, DURING AN AORTIC-ILIAC-FEMORAL INTERVENTION, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. A COOK 6 FRENCH X 55-CENTIMETER HI-FLEX STRAIGHT ANSEL SHEATH WAS USED DURING THE PROCEDURE, AS WELL AS A COOK SPHERE INFLATION DEVICE. ACCESS WAS GAINED IN THE RIGHT ILIAC ARTERY AND A CONTRALATERAL APPROACH WAS USED. THE VESSELS WERE REPORTEDLY TORTUOUS, CALCIFIED, AND VERY SMALL. UPON THE INITIAL INFLATION TO PRE-DILATE THE 85% OCCLUDED LESION, PRIOR TO PLACING A STENT, THE BALLOON REPORTEDLY RUPTURED ON A PIECE OF CALCIUM WITHIN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS REMOVED BY ITSELF, OVER AN UNKNOWN WIRE GUIDE. ANOTHER MANUFACTURER'S BALLOON WAS THEN USED; HOWEVER, THIS BALLOON ALSO RUPTURED. A THIRD (OTHER MANUFACTURER'S) BALLOON WAS USED TO COMPLETE THE INTENDED PROCEDURE. THE COMPLAINT DEVICE WAS NOT INFLATED WITHIN A STENT PRIOR TO RUPTURING. 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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136979 ↗
• MalfunctionApr 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERIOGRAM, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DEVICE RUPTURED AT 8 ATMOSPHERES (ATM), PRIOR TO REACHING NOMINAL PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. ACCORDING TO THE INITIAL REPORTER, 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451284 ↗
• MalfunctionMar 9, 2017Material Rupture; Material Rupture

  IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED TO TREAT SEVERE CALCIFIED LESION OF THE EXTERNAL ILIAC ARTERY, BY WAY OF THE BRACHIAL ARTERY, HOWEVER THE BALLOON RUPTURED. ANOTHER ADVANCE 35 LP WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393015 ↗
• MalfunctionDec 22, 2016Deflation Problem; Deflation Problem

  RECOIL OF THE PATIENT'S STENOSIS WAS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6200327 ↗