Advance G52367Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002523675), received between Apr 9, 2015 and Aug 28, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Balloon rupture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2017Material Rupture; Torn Material; Material Rupture; Torn Material

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN A SUBAORTAL PROCEDURE. IT WAS REPORTED THAT, DURING THE PROCEDURE THE BALLOON CATHETER SLIPPED LONGITUDINALLY AND WAS TORN. DURING REMOVAL OF THE BALLOON CATHETER A PIECE OF THE BALLOON WAS LEFT IN THE PATIENT. THE SURGEON HAD TO OPEN THE VESSEL TO REMOVE THE PIECE OF BALLOON. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6824340 ↗
• InjuryApr 9, 2015Balloon rupture; Material Separation

  THE CONSULTANT INTERVENTIONAL RADIOLOGIST A LEFT COMMON ILIAC ANGIOPLASTY +/- STENTING PROCEDURE ON THE MALE PATIENT, WHO HAD PRE-EXISTING CONDITION OF LEFT COMMON ILIAC DISEASE. IT WAS NOTED THAT THERE WAS VERY TIGHT STENOSIS LOCATED IN THE LEFT COMMON ILIAC ARTERY. THE CONSULTANT INTERVENTIONAL RADIOLOGIST CROSSED WITH A WIRE GUIDE AND ANOTHER MANUFACTURER'S 8MM X 6CM BALLOON WAS INFLATED. THE RESULT WAS SUB OPTIMAL SO IT WAS DECIDED TO USE COOKS' 9MM X 6CM ADVANCE 35 BALLOON AND INFLATED TO 5-6 ATMOSPHERES. AT THIS POINT, IT WAS NOTED THAT THE BALLOON HAD BURST, SO THE WIRE GUIDE WAS INSERTED FURTHER AS A PRECAUTION, THE CONSULTANT INTERVENTIONAL RADIOLOGIST ATTEMPTED TO PULL BACK THE BALLOON CATHETER. RESISTANCE WAS FELT AND MORE TENSION WAS APPLIED ON THE BALLOON CATHETER. THE CONSULTANT INTERVENTIONAL RADIOLOGIST FELT SOMETHING GIVE AND THE BALLOON CATHETER WAS REMOVED FROM THE INTRODUCER SHEATH. IT WAS NOTED THAT THE DISTAL PORTION OF THE BALLOON CATHETER AND TIP WERE NOT ATTACHED. THE WIRE WAS CLIPPED TO KEEP IN PLACE AND THE PATIENT WAS TAKEN TO THEATRE (SURGERY) FOR A SURGICAL CUTDOWN TO REMOVE THE FOREIGN OBJECT WITH SURGICAL FORCEPS. A SECTION OF THE DEVICE REMAINED WIT

  Patient problems: Foreign body, removal of; Surgical procedure, additional

  MAUDE report 4685488 ↗