Advance G50224Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002502243), received between Jul 13, 2017 and Jan 28, 2022 — classified as 3 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 18, 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.

• MalfunctionJan 28, 2022Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE A ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS FOUND NOT TO INFLATE DUE TO A LEAK. THE BALLOON CATHETER WAS ADVANCED TO THE POPLITEAL ARTERY VIA A COOK GUIDING SHEATH. THE USER BEGAN INFLATING WITH A BALLOON EXPANSION PRESSURE PUMP, BUT UPON INFLATING THEY FOUND THAT PRESSURE COULD NOT BE MAINTAINED AND THE CONTRAST SUBSTANCE WAS LEAKING FROM THE BALLOON. NO ANGULATION OR VESSEL TORTUOSITY WAS NOTED. THE BALLOON WAS THEN REMOVED WITH THE SHEATH. ANOTHER NEW BALLOON CATHETER 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. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384697 ↗
• MalfunctionAug 24, 2017Hole In Material; Inflation Problem; Hole In Material; Inflation Problem

  AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED IN A TIBIAL ANGIOPLASTY. IT WAS REPORTED, THE BALLOON HAD A HOLE IN IT AND WAS UNABLE TO BE INFLATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. IT HAS NOT BEEN REPORTED THAT THE PATIENT REQUIRED 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 6816705 ↗
• MalfunctionJul 13, 2017Burst Container or Vessel

  THE INFORMATION RECEIVED INDICATED THAT WHEN THE VASCULAR SURGEON INFLATED THE BALLOON TO RATED BURST PRESSURE OF 14 ATM IN THE POSTERIOR TIBIAL, THE BALLOON BURST. THE BALLOON WASN'T KEPT. A PIECE OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT, THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT ASSOCIATED WITH THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710684 ↗