Advance G52347Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002523477), received between Jul 28, 2017 and Apr 27, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING AN ENDOVASCULAR TREATMENT PROCEDURE, A HOLE WAS FOUND ON AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY, AND THE COMPLAINT DEVICE WAS ADVANCED TO A LESION IN THE LEFT EXTERNAL ILIAC ARTERY. UPON ATTEMPTED INFLATION, THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT AND A PINHOLE WAS FOUND ON THE BALLOON. ANOTHER BALLOON OF A DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220095 ↗
• MalfunctionMay 22, 2019Crack; Crack

  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 8633531 ↗
• MalfunctionOct 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING AN ANGIOPLASTY PROCEDURE PATIENT'S FOREARM ARTERIOVENOUS SHUNT, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY UPON INFLATION. INFLATION PRESSURE NOT KNOWN BUT REPORTEDLY WAS UNDER THE NOMINAL PRESSURE. TYPE OF CONTRAST IS UNKNOWN. THERE WAS NO ANGULATION OR CALCIFICATION OF THE PATIENT'S ANATOMY. THE COMPLAINT DEVICE WAS REMOVED AND ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY 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 7993736 ↗
• MalfunctionApr 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED AT 15 BAR WHEN INFLATED. SUBSEQUENTLY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS REMOVED AND ANOTHER MANUFACTURER'S DEVICE 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. ADDITIONAL QUESTIONS REGARDING DETAILS OF THE EVENT HAVE BEEN ASKED, BUT ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7408247 ↗
• MalfunctionJul 28, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT OF A LESION IN THE LEFT EXTERNAL ILIAC ARTERY THE ADVANCE 35 LP LOW PROFILE BALLOON BURST. THE APPROACH WAS IPSILATERAL FROM THE LEFT COMMON FEMORAL ARTERY, DESCRIBED AS HAVING SEVERE CALCIFICATION EXTENDING FROM THE COMMON FEMORAL ARTERY TO THE EXTERNAL ILIAC ARTERY. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES WHEN THE BURST OCCURRED. THE DIRECTION OF BURST IS UNKNOWN. ANOTHER MANUFACTURER'S BALLOON, THE "MUSTANG/BSJ," WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6751976 ↗