Advance G50254Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502540), received between Jun 30, 2016 and Jun 30, 2016 — classified as 1 injury.

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 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.

• InjuryJun 30, 2016Burst Container or Vessel; Burst Container or Vessel

  FIRST THE STENOSIS WAS DILATED WITH ENFORCER 6MM IN DIAMETER WITH A SUB-OPTIMAL RESULT. ATTEMPT TO DILATE WITH A 7MM PTA BALLOON (PTA4-18-80-7-2). THE BALLOON WAS INFLATED UP TO 20 ATM AT WHICH PRESSURE THE BALLOON BURST. WHILE RETRIEVING THE BALLOON THROUGH THE SHEATH THE BALLOON GOT STUCK TO THE SHEATH. HEAVY FORCE WAS APPLIED TO REMOVE THE BALLOON. PHYSICIAN SUCCEEDED IN REMOVING THE BALLOON, BUT THE DISTAL PART OF THE BALLOON WAS COMPLETELY STRETCHED AND THE DISTAL PART OF THE BALLOON WAS ONLY STILL THERE BECAUSE IT WAS ON THE TERUMO WIRE GUIDE. INSPECTION OF THE BALLOON REVEALED THAT THE BALLOON HAD RUPTURED IN THE WRONG DIRECTION. 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. 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 5761611 ↗