IN.PACT™ Admiral™ ADM06006008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169383227), received between Apr 24, 2019 and May 15, 2020 — classified as 4 injuries.

1 other recall cover devices cleared under the same FDA submission (P140010); they may or may not involve this specific model.

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.

• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT ADMIRAL DEB WAS USED TO TREAT THE PROXIMAL SFA (R1). APPROXIMATELY 12 MONTHS LATER THE PATIENT SUFFERED RESTENOSIS OF THE SUPERFICIAL FEMORAL ARTERY TREATED WITH HOSPITALIZATION AND PTA AND BARE METAL STENTING OF THE TARGET LESION (R1). THE PATIENT RECOVERED. THE EVENT WAS STATED AS PROBABLY RELATED TO THE TARGET LIMB, VESSEL, LESION AND AN UNDERLYING CONDITION; AND NOT RELATED TO THE DISEASE UNDER STUDY. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 10060360 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE IN.PACT ADMIRAL DCB WERE USED TO TREAT THE RIGHT POPLITEAL (R1) AND THE RIGHT MID AND DISTAL SFA(R2). DISSECTION OCCURRED BUT NO STENTING WAS CARRIED OUT. APPROXIMATELY 8.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA AND WAS TREATED WITH A PTA OF THE RIGHT POPLITEAL (R1) AND THE RIGHT DISTAL SFA (R2). THE EVENT IS RESOLVED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 9271974 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN PACT ADMIRAL DCB WAS USED TO TREAT THE RIGHT MID SFA (R1). APPROXIMATELY 7 MONTHS LATER THE PATIENT HAD RIGHT MIDDLE SFA RESTENOSIS (TARGET LESION) AND THIS WAS TREATED WITH PTA OF THE TARGET LESION AND MEDICATION. THE INVESTIGATOR AND SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE, PROCEDURE OR THERAPY. THE PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 8553921 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT ADMIRAL DCB WAS USED TO TREAT THE RIGHT MID SFA. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED SUPERFICIAL FEMORAL ARTERY AND COMMON FEMORAL ARTERY CONSTRICTION. THE EVENT WAS TREATED WITH SFA TO POPLITEAL BYPASS GRAFT AND PTA. PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE PACLITAXEL AND UNLIKELY RELATED TO THE DEVICE OR PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8543547 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140010. One submission often covers many models, so check the product and lot details in each record.

• Z-1042-2022 · Mar 23, 2022 · Open, Classified
  Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM040120