Admiral™ Xtreme ADM050300130LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477064109), received between Jan 28, 2021 and Jan 14, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJan 14, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE AN ADMIRAL XTREME BALLOON DILATATION DEVICE TO TREAT A PATIENT IN THE LEFT PROX/DISTAL PERIPHERAL ARTERY(S) SUPERFICIAL FEMORAL ARTERY REPORTED TO BE CALCIFIED. IFU WAS FOLLOWED. VESSEL WAS POST DILATED. IT WAS REPORTED THAT THE THE ADMIRAL XTREME BALLOON BURST AT, BELOW, OR UNKNOWN RATED BURST PRESSURE DURING FIRST INFLATION. 50/50 CONTRAST WAS USED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND A NEW ADMIRAL XTREME WAS USED WITH NO ISSUES REPORTED. NO HEALTH CONSEQUENCES OR IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146947 ↗
• InjuryJan 28, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE AN ADMIRAL XTREME PTA BALLOON DURING TREATMENT OF A PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. AN EVEREST INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED DURING WITHDRAWAL OF THE DEVICE THROUGH THE SHEATH A BREAK/FRACTURE OCCURRED ON THE BALLOON AND CATHETER. THE DETACHED PORTIONS OF THE DEVICE WERE REMOVED USING A SNARE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244510 ↗