IN.PACT™ Admiral™ ADM05004008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169383555), received between Apr 5, 2019 and Jun 5, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO INPACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE DISTAL SFA AND POPLITEAL ARTERY OF THE RIGHT LIMB (R-1). APPROX 11 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED RIGHT SFA RESTENOSIS. THE PATIENT WAS TREATED WITH PTA OF THE TARGET LESION. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE INDEX PROCEDURE OR PACLITAXEL. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE INDEX PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 8669731 ↗
• InjuryApr 5, 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, TWO TO THE TREAT THE LEFT POPLITEAL AND ONE TO TREAT THE RIGHT POPLITEAL. DISSECTION WAS REPORTED DURING THE PROCEDURE BUT NO STENTING WAS CARRIED OUT. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT POPLITEAL ARTERY STENOSIS. CYANOSIS OF LEFT FOOT WAS CONFIRMED BY ANGIO. EVENT WAS TREATED WITH PTA OF TARGET LESION. INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE, AND NOT RELATED TO THE PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 8486811 ↗

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