Advance G50227Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002502274), received between Aug 7, 2018 and Jun 20, 2024 — classified as 3 malfunctions.

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

• MalfunctionJun 20, 2024Break; Break

  AS REPORTED, DURING A BALLOON DILATION OF THE "LEFT PYELO-URETERAL SCHEDULE", AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER SEPARATED. THE BALLOON WAS ADVANCED OVER ANOTHER MANUFACTURER'S GUIDEWIRE AND THROUGH ANOTHER MANUFACTURER'S CYSTOSCOPE THROUGH THE URETHRA. ANOTHER MANUFACTURER'S CATHETER WAS USED FOR CONTRAST INTRODUCTION. THE BALLOON WAS INFLATED IN THE LEFT SKYLE-URETERAL JUNCTION TO FOURTEEN ATMOSPHERES ONE TIME FOR THREE MINUTES. ONCE THE BALLOON WAS COMPLETELY DEFLATED AND RETURNED TO AMBIENT PRESSURE, A COUNTERCLOCKWISE ROTATION WAS USED TO REMOVE THE BALLOON WHILE MAINTAINING NEGATIVE PRESSURE. THE REMOVAL WAS CONTROLLED WITH MICROSCOPY (X-RAY). UPON REACHING THE URETERO-VESICAL JUNCTION, THE USER ENCOUNTERED PROBLEMS/DIFFICULTY WITH REMOVAL. THE USER MADE NEGATIVE PRESSURE WITH THE NANOMETER AND TURNED THE BALLOON. THE CYSTOSCOPE WAS REMOVED FROM THE PATIENT, FOLLOWED BY THE BALLOON CATHETER. "FORCE" WAS USED TO REMOVE THE BALLOON AND ONCE REMOVED, THE BALLOON CATHETER WAS BROKEN. THE CYSTOSCOPE WAS REINSERTED, AND REMAINS OF THE BALLOON WERE FOUND. THE REMAINS WERE SUCCESSFULLY REMOVED WITH FORCEPS/TWEEZERS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575903 ↗
• MalfunctionJan 16, 2019Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253006 ↗
• MalfunctionAug 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LEAKED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7758762 ↗