ADMIRAL XTREME ADM070040080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477058078), received between Oct 7, 2017 and Oct 7, 2017 — 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 18, 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.

• InjuryOct 7, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE THE ADMIRAL XTREME PTA TO TREAT THE RIGHT ILIAC ARTERY. IT WAS REPORTED THE BALLOON WAS ADVANCED TO THE LESION, AND INFLATED ACROSS THE RIGHT ILIAC LESION AT 8 ATMOSPHERES FOR 60 SECONDS. DURING THE SECOND INFLATION AFTER 3 MINUTES THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE BALLOON WAS REMOVED OVER A WIRE, IT WAS OBSERVED AFTER REMOVAL THAT A FRAGMENT OF THE BALLOON WAS CAUGHT AT THE SHEATH. THE PHYSICIAN PULLED THE SHEATH SLIGHTLY BACK AND WITH A BLADE CUT DOWN AND WITH HEMOSTATS RETRIEVED THE FRAGMENTED BALLOON PIECE. THE SHEATH WAS ADVANCED BACK AND HELD PRESSURE. THE SITE CONTINUED TO BLEED THE PHYSICIAN UPSIZED THE SHEATH FROM A 5F,6F,7F,8F TO A 9F SHEATH AND APPLIED PRESSURE. THE SIGHT STOPPED BLEEDING WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6926171 ↗