Admiral™ Xtreme ADM060300130LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033477064383), received between May 16, 2019 and May 6, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN ADMIRAL XTREME DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY (POP). THE VESSEL WAS SEVERELY TORTUOUS. THERE WAS NO DAMAGE NOTED TO PACKAGING FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. NO INFLATION FLUID WAS USED. BALLOON BURST OCCURRED AT 8ATM DURING BALLOON INFLATION. THERE WERE 2 INFLATIONS APPLIED PRIOR TO BURST. THE BALLOON DID NOT FRAGMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. THE PROCEDURE WAS COMPLETED BY USING A 6 X 150 EVERCROSS PTA BALLOON. NO VESSEL DAMAGE NOTED DUE TO EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14303702 ↗
• MalfunctionAug 12, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN ADMIRAL XTREME PTA BALLOON WITH A 6FR SHEATH DURING TREATMENT OF A 200MM CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL DIAMETER REPORTED AS 6MM. SEVERE VESSEL CALCIFICATION IS REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED A LONGITUDINAL BALLOON BURST OCCURRED AT A PRESSURE OF 10ATM ON FIRST INFLATION. THE BALLOON WAS REMOVED FROM THE PATIENT WITH NO REMAINING COMPONENTS AND WAS REPLACED WITH A NON-MEDTRONIC 6X200 BALLOON TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395141 ↗
• MalfunctionJul 8, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN ADMIRAL XTREME DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY OR CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. NO RESISTANCE WAS REPORTED WHEN ADVANCING THE DEVICE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED A BALLOON BURST OCCURRED. THE BALLOON DID NOT FRAGMENT. NO DIFFICULTY WAS NOTED REMOVING THE DEVICE FROM THE PATIENT, AND NO INTERVENTION WAS REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243631 ↗
• MalfunctionMay 16, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION(CTO) 100% STENOTIC FIBROUS LESION IN THE MID/DISTAL/PROXIMAL SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 6MM <(>&<)> 300MM, RESPECTIVELY. THE LESION WAS PRE-DILATED WITH A 6X300X130ADMIRAL XTREME BALLOON. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE BALLOON FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 7FR NON-MEDTRONIC SHEATH ALONG WITH A 0.035 NON MEDTRONIC WITH NO EMBOLIC PROTECTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE APPLIED WHEN ACCESSING THE LESION. ON FIRST INFLATION TO 6ATM, THE BALLOON BURST. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE PATIENT. A NEW 6X300 ADMIRAL XTREME BALLOON WAS USED TO COMPLETE THE PRE-DILATION. THE EVERFLEX STENT WAS THEN INTRODUCED BUT IT WAS REPORTED THAT THE STENT GOT STUCK ON THE 0.035 WIRE. THE STENT AND WIRE HAD TO BE REMOVED AS A UNIT. THE STENT WAS REPORTED TO HAVE FLARED AT THE DISTAL TIP. A NEW WIRE WAS THEN USED TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615790 ↗