Admiral™ Xtreme ADM050250130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477064093), received between Sep 2, 2025 and Sep 2, 2025 — classified as 2 malfunctions.

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.

• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A CALCIFIED LESION IN THE MID AND DISTAL SEGMENTS OF THE LEFT SUPERFICIAL FEMORAL ARTERY, TWO ADMIRAL XTREME BALLOONS EXPERIENCED BALLOON BURSTS ON THE FIRST INFLATION. THE BALLOONS WERE INFLATED USING A NON MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST INFLATION FLUID. THE FIRST DEVICE WAS SAFELY REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW 5 X 250 ADMIRAL XTREME DEVICE. THE SECOND DEVICE WAS ALSO SAFELY REMOVED, BUT THE PROCEDURE WAS ABORTED. NO BALLOON DETACHMENT OCCURRED. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935972 ↗
• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A CALCIFIED LESION IN THE MID AND DISTAL SEGMENTS OF THE LEFT SUPERFICIAL FEMORAL ARTERY, TWO ADMIRAL XTREME BALLOONS EXPERIENCED BALLOON BURSTS ON THE FIRST INFLATION. THE BALLOONS WERE INFLATED USING A NON MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST INFLATION FLUID. THE FIRST DEVICE WAS SAFELY REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW 5 X 250 ADMIRAL XTREME DEVICE. THE SECOND DEVICE WAS ALSO SAFELY REMOVED, BUT THE PROCEDURE WAS ABORTED. NO BALLOON DETACHMENT OCCURRED. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935966 ↗