Advance G50330Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002503301), received between Jul 21, 2017 and Feb 5, 2021 — classified as 4 malfunctions.

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

• MalfunctionFeb 5, 2021Crack; Crack

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11284882 ↗
• MalfunctionAug 7, 2018Material Separation; Material Separation

  IT WAS REPORTED, THE SHAFT OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BROKE DURING A TIBIAL ARTERY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). PER THE PHYSICIAN, THERE WAS NO PROBLEM WITH THE DEVICE'S HYDROPHILIC COATING. IT WAS ACTIVATED USING SALINE SOAKED GAUZE PRIOR TO THE PROCEDURE. IT IS UNCLEAR IF A COMPETITOR'S BALLOON CATHETER WAS USED OR IF THE ISSUE WAS NOTED AFTER THE COMPLETION OF THE PROCEDURE; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7758833 ↗
• MalfunctionApr 2, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE PROXIMAL END OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS FOUND TO BE UNRAVELED PRIOR TO USE DURING AN UNKNOWN PATIENT PROCEDURE. ANOTHER ONE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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 7389403 ↗
• MalfunctionJul 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD A LOWER LEG ANGIOGRAM. DURING USE OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED. THE INFLATION PRESSURE USED WAS 6 ATM. IT IS UNKNOWN THE TYPE OF CONTRAST OR THE MIX OF CONTRAST TO SALINE THAT WAS USED . THE LESION WAS LOCATED IN THE TIBIAL PERINEAL TRUNK. THERE WAS VESSEL CALCIFICATION NOTED BUT NO ANGULATION. IT IS UNKNOWN WHETHER THE BALLOON BURST CIRCUMFERENTIALLY OR LONGITUDINALLY. NO UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT'S BODY. THERE ARE NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730938 ↗