Advance G50252Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502526), received between Jul 19, 2017 and Jul 19, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2017Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY PROCEDURE USING AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER, THE SHAFT OF THE BALLOON BROKE OFF INSIDE THE PATIENT DURING THE CASE. THE PATIENT REQUIRED SURGERY TO HAVE THE DEVICE PORTION REMOVED AS THE BALLOON WAS UNABLE TO BE SNARED. THE BALLOON RUPTURED AS THE LESION WAS CALCIFIED CAPTURED IN MEDWATCH WITH NUMBER 1820334-2017-01662. THE PATIENT REQUIRED ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AS THE DEVICE PORTION HAD TO BE SURGICALLY REMOVED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION INCLUDING REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE HAVE BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6724375 ↗