IN.PACT™ Admiral™ ADM05020013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169975019), received between Nov 16, 2018 and Aug 19, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2021Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE INPACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER DURING PROCEDURE TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED USING AN INFLATION DEVICE. THERE WAS NO DAMAGED NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. REMOVAL DIFFICULTIES OCCURRED. IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING BALLOON FOLLOWING INFLATION. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THERE WERE NO DIFFICULTIES NOTED DURING BALLOON DEFLATION. THE BALLOON WAS FULLY DEFLATED WHEN REMOVAL ATTEMPT MADE. THE SHEATH AND INPACT ADMIRAL WERE REMOVED IN TANDEM. NO INTERVENTION REQUIRED FOR REMOVAL. DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340783 ↗
• MalfunctionAug 9, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE AN IN.PACT ADMIRAL FOR PATIENT TREATMENT OF THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE VESSELS WERE CALCIFIED WITH NO DEGREE OF TORTUOSITY AND MODERATE DEGREE OF CALCIFICATION WITH 50% LESION STENOSIS. IFU WAS FOLLOWED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE PASSED THOUGH A PREVI OUSLY-DEPLOYED STENT. NO RESISTANCE OR EXCESSIVE FORCE WAS NOTED DURING ADVANCEMENT. IT WAS REPORTED THAT BALLOON BURST OCCURRED AT 6 ATMS. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A REPLACED BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293455 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A HAWKONE AND A 5 X 100 IN.PACT ADMIRAL DURING TREATMENT OF A MODERATELY CALCIFIED PLAQUE LESION IN THE RIGHT PROXIMAL SFA WITH 80% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5.5MM AND 80MM RESPECTIVELY. THE VESSEL IS LITTLE TORTUOUS A NON MEDTRONIC 6FR SHEATH, MEDTRONIC 0.014 GUIDE WIRE AND 5MM SPIDER FX WERE USED. A SMALL DISSECTION WAS NOTICED AT THE TARGET LESION POST HAWK USAGE. THE PHYSICIAN DECIDED TO GO IN WITH THE DRUG COATED BALLOON AND THE DISSECTION EXTENDED FROM THE ORIGINAL. A STENT WAS THEN PLACED ACROSS THE DISSECTION. AN EVERCROSS PTA BALLOON WAS ATTEMPTED TO CROSS THE NEWLY DEPLOYED STENT BUT IT FAILED. THERE WAS NOT DAMAGE TO DEVICE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUED IDENTIFIED. THERE WAS SEVERE RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NANOCROSS PTA BALLOON WAS USED TO CROSS THE LESION AND COMPLETE THE PROCEDURE. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 10161559 ↗
• MalfunctionApr 16, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  THE PHYSICIAN USED A SPIDER FX WITH A NON-MEDTRONIC 7 FR SHEATH, A 0.014 GUIDEWIRE AND AN IN.PACT ADMIRAL DCB TO TREAT A SEVERELY CALCIFIED LESION WITH CTO (CHRONIC TOTAL OCCLUSION 100%) IN THE MID LEFT POPLITEAL ARTERY. LESION LENGTH AND ARTERY DIAMETER WERE RESPECTIVELY 150 MM AND 6 MM. THE VESSEL PRESENTED MODERATE TORTUOSITY. IFU WAS FOLLOWED. NEGATIVE PREP WAS PERFORMED ON THE BALLOON. NO LEAKAGE WAS OBSERVED. IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED WHEN PULLING THE FILTER INTO THE TIP AND INSERTING INTO THE SHEATH DURING PREP. THE SPIDER CATHETER WAS DELIVERED OVER THE 0.014 GUIDEWIRE AND THEN THE GUIDEWIRE WAS REMOVED AS PER THE IFU. WHEN TRYING TO ADVANCE THE SPIDER FILTER THROUGH THE DISTAL END OF THE CATHETER, IT WOULD NOT ADVANCE AND SEEMED PROLAPSED WITHIN THE DELIVERY SYSTEM. NO DETACHMENT OCCURRED. THE ENTIRE SYSTEM WAS THEN PULLED AND A NEW SPIDER WAS DELIVERED THROUGH AN .035 NON-MEDTRONIC WIRE (GLIDEWIRE) AND A 135 TRAILBLAZER. AFTER THE SYSTEM WAS REPLACED, THE PHYSICIAN PROGRESSED WITH THE IN.PACT ADMIRAL DCB. IF U WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUED IDENTIFIED. AN UNKNOWN INFLATION DEVICE WAS USED AND INFLATION DIFFICULTY WAS REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517425 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN INTENDED TO USE THE INPACT ADMIRAL TO TREAT A CTO (CHRONIC TOTAL OCCLUSION) IN THE RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERY, TO TREAT IN-STENT RESTENOSIS. A SECONDARY INTERVENTION WAS CARRIED OUT. THE PROCEDURE WAS CARRIED OUT BY OVERLAPPING THE BALLOON BY AT LEAST 3CM AND EXTENDING THE DCB (DRUG COATED BALLOON) BY AT LEAST 1CM BEYOND THE LESION BOTH PROXIMALLY AND DISTALLY. IT WAS REPORTED 365 POST PROCEDURE THE PATIENT WAS TREATED FOR RESTENOSIS OF THE SAME VESSEL.

  Patient problems: Reocclusion

  MAUDE report 8077926 ↗