Advance G50256Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002502564), received between Aug 12, 2016 and Jul 12, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2017Burst Container or Vessel

  WHEN THE VASCULAR SURGEON INFLATED THE BALLOON TO RATED BURST PRESSURE OF 14 ATM IN THE SUPERIOR FEMORAL ARTERY (SFA), THE BALLOON BURST. NO PIECE OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS EVENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708695 ↗
• InjuryAug 12, 2016Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED DURING A FISTULAPLASTY, USING ANOTHER MANUFACTURER'S SHEATH, THE BALLOON CATHETER BURST CIRCUMFERENTIALLY BELOW THE INFLATION PRESSURE LIMITS. THE TIP OF THE BALLOON POLYMER TIP DETACHED FROM THE BALLOON A VASCULAR SNARE WAS USED TO REMOVE THE FRAGMENT. THE REPORTER STATED SHE WAS "UNSURE, PERHAPS SOME OFF THE BALLOON MATERIAL" REMAINED IN THE PATIENT AND THAT ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THE EVENT. THE PATIENT REPORTEDLY EXPERIENCED EXTRA BRUISING, PAIN AND WAS EXPOSED TO ADDITIONAL RADIATION DUE TO THE ADVERSE EVENT.

  Patient problems: No Code Available; Pain

  MAUDE report 5871529 ↗