IN.PACT™ Admiral™ ADM07006013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169383357), received between Aug 27, 2018 and Mar 30, 2020 — classified as 2 injuries.

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

• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HAWKONE DEVICE WAS USED TO TREAT A 20MM CALCIFIED LESION IN THE PATIENTS¿ MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. LESION EXHIBITED 80% STENOSIS. SLIGHT VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION REPORTED. PRE-DILATION WAS NOT PERFORMED. NO ISSUES REPORTED DURING USE OF THE DEVICE. FOUR PASSES WERE COMPLETED, AND IT IS REPORTED THE ARTERY DIAMETER HAD INCREASED LARGER THAN BASELINE. ANGIOPLASTY WAS PERFORMED USING AN INPACT ADMIRAL DCB AND PATIENT WAS DISCHARGED FROM HOSPITAL. ROUTINE FOLLOW-UP HAS SHOWN THE COMMON FEMORAL CONTINUING TO INCREASE. ALMOST 2 YEARS POST-PROCEDURE, THE VESSEL IS REPORTED TO NOW BE APPROXIMATELY 2.5 CM IN DIAMETER. PATIENT IS REPORTED TO HAVE ANEURYSM OF COMMON FEMORAL ARTERY. THE HAWKONE IS SUSPECTED TO HAVE BEEN A CONTRIBUTOR TO THE EVENT. PATIENT WAS REFERRED TO VASCULAR SURGEON.

  Patient problems: Aneurysm

  MAUDE report 9896704 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A NON-MEDTRONIC DEVICE WAS USED TO TREAT THE VENOUS OUTFLOW. APPROXIMATELY 7 WEEKS LATER, REVASCULARIZATION OF THE ANASTOMOSIS WAS CARRIED OUT USING AN IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER. APPROXIMATELY 6 WEEKS POST REVASCULARIZATION, PATIENT SUFFERED RECURRENT AVF STENOSIS WITH REVASCULARIZATION OF THE ANASTOMOSIS CARRIED OUT SAME DAY USING AN ADMIRAL XTREME PTA BALLOON. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO THE STUDY DEVICE, PROCEDURE OR PACLITAXEL. SPONSOR ASSESSED EVENT IS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 7817450 ↗