Advance G52254Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002522548), received between Jul 13, 2018 and Oct 19, 2023 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. A COOK SHEATH AND WIRE GUIDE WERE USED DURING THE PROCEDURE. THE ANATOMY WAS REPORTEDLY NOT TORTUOUS OR CALCIFIED. VENOPLASTY WAS PERFORMED FOR RIGHT BRACHIOCEPHALIC STENOSIS. THE BALLOON WAS INFLATED TO AN UNKNOWN PRESSURE; HOWEVER, THE BALLOON REPORTEDLY RUPTURED. THE BALLOON RETURNED TO AMBIENT PRESSURE AND NEGATIVE PRESSURE WAS MAINTAINED UPON ATTEMPTED REMOVAL OF THE DEVICE; HOWEVER, A COUNTERCLOCKWISE ROTATION WAS NOT CONDUCTED. THE BALLOON CATHETER WAS UNABLE TO BE REMOVED OVER THE WIRE; THEREFORE, THE BALLOON CATHETER AND THE WIRE GUIDE WERE REMOVED TOGETHER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17965168 ↗
• InjurySep 11, 2018Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Perforation of Vessels

  MAUDE report 7865404 ↗
• MalfunctionJul 13, 2018Inflation Problem; Material Rupture; Material Integrity Problem; Inflation Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED, DURING TREATMENT OF FEMORAL ARTERY OCCLUSIONS OF THE PATIENT'S LOWER EXTREMITIES, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER COULD NOT BE INFLATED. THE PHYSICIAN ADVANCED THE BALLOON THROUGH THE CALCIFIED ARTERY TO THE TARGET SITE. AFTER DISCOVERING THE COMPLAINT DEVICE WOULD NOT INFLATE, IT WAS WITHDRAWN. A SPLIT WAS FOUND IN THE BALLOON. A 6 FRENCH SHEATH WAS BEING UTILIZED DURING THE PROCEDURE. SUBSEQUENTLY, THE COMPLAINT DEVICE WAS CHANGED FOR A NEW BALLOON CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 7686640 ↗