IN.PACT™ Admiral™ ADM05004013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169383609), received between Oct 5, 2018 and Oct 2, 2024 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 23, 2022Class IIOpen, Classified

   Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

   Z-1042-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

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.

• MalfunctionOct 2, 2024Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS USING AN IN.PACT ADMIRAL BALLOON FOR TREATMENT OF A 15MM CALCIFIES LESION WITH 70% STENOSIS IN THE DISTAL REGION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 5MM IN DIAMETER WITH MODERATE CALCIFICATION AND NO TORTUOSITY. A 6FR NON MEDTRONIC SHEATH AND A 0.035" NON MEDTRONIC GUIDEWIRE WAS USED. THE VESSEL WAS PRE DILATED WITH 2 5MM BALLOONS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE DURING ADVANCEMENT. A NON MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST INFLATION FLUID WAS USED. THE IFU WAS FOLLOWED. IT WAS REPORTED DURING THE FIRST INFLATION AT 8ATM THE BALLOON BURST. THE TYPE OF BALLOON BURST IS UNKNOWN. THERE WAS NO INJURY OR INTERVENTION ASSOCIATED WITH THIS EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER IN.PACT ADMIRAL WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350253 ↗
• MalfunctionMay 3, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN INPACT ADMIRAL BALLOON TO TREAT A SEVERELY CALCIFIED, NON-TORTUOUS CHRONIC TOTAL OCCLUSION(CTO, 100%) LESION IN THE MID LEFT POPLITEAL ARTERY. THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 5 MM <(>&<)> 40 MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. A 6FR NON-MEDTRONIC SHEATH AND A 0.014 GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO 8 ATM FOR 3 MINS. THE BALLOON WAS REPORTED TO HAVE BURST. ALL BALLOON FRAGMENTS WERE RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577195 ↗
• MalfunctionOct 23, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL WITH A NON-MEDTRONIC 6FR SHEATH AND NON-MEDTRONIC GUIDEWIRE FOR TREATMENT OF A 85-90% STENOSED LESION BETWEEN TWO STENTS IN THE PATIENTS MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS DESCRIBED AS BEING MODERATELY CALCIFIED. NO DAMAGE WAS NOTED TO PACKAGING PRIOR TO USE. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE IFU WAS FOLLOWED DURING PREP. PRE-DILATION WAS CARRIED OUT USING A 4MM PTA BALLOON PRIOR TO USE OF THE IN.PACT ADMIRAL WITHOUT ISSUE. IT WAS REPORTED THAT THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED OR EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE BALLOON BURST AT AN INFLATION PRESSURE OF 9ATM ON FIRST INFLATION. THE ENTIRE BALLOON WAS REMOVED AND DID NOT FRAGMENT. NO ADVERSE EVENT WAS REPORTED. THE LESION WAS TREATED WITH ANOTHER IN.PACT ADMIRAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7995858 ↗
• DeathOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE TWO INPACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETERS WERE USED TO TREAT THE RIGHT MID TO DISTAL SFA. APPROXIMATELY 2 MONTHS MOST PROCEDURE, PATIENT EXPIRED. PATIENT WAS TREATED IN ANOTHER HOSPITAL, EVENT DETAILS ARE UNKNOWN. INVESTIGATOR ASSESSMENT IS NOT REPORTED.

  Patient problems: Death

  MAUDE report 7939075 ↗