Advance G52282Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002522821), received between Jun 30, 2017 and Jun 30, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A POST TPA DRIP USING AN ADVANCE 35 LOW PROFILE BALLOON CATHETER, THE BALLOON GOT STUCK IN THE PATIENT'S ILIAC VEIN. IT WAS STATED THAT THERE WAS ANGULATION TO THE ILIAC VEIN. WHEN PULLED NEGATIVE, BLOOD CAME INTO SYRINGE. THE DEVICE SHAFT WAS CUT AND THE WIRE WAS REINSERTED. THE BALLOON HAD TO BE RETRIEVED AND SNARED FROM THE OPPOSITE SIDE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY AND THERE WERE NO REPORTED ADVERSE EVENTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 6681572 ↗