IN.PACT™ Admiral™ ADM04006008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169383463), received between Dec 20, 2018 and Aug 30, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 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 TARGET LESION (R1) APPROXIMATELY TWO WEEKS LATER. 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 8949143 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO INPACT ADMIRAL DRUG ELUTING BALLOONS WERE USED TO TREAT THE SFA. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED SFA RESTENOSIS IN THE LEFT FOOT. STANDARD PTA WAS PERFORMED SAME DAY. THE PATIENT IS RECOVERING. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DRUG, AND PROBABLY RELATED TO DEVICE AND PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DRUG, AND PROBABLY RELATED TO DEVICE AND PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 8183669 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO IMPACT ADMIRAL DRUG ELUTING BALLOONS WERE USED TO TREAT THE SFA. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED SFA RESTENOSIS IN THE LEFT FOOT. STANDARD PTA WAS PERFORMED SAME DAY. THE PATIENT IS RECOVERING. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DRUG, AND PROBABLY RELATED TO DEVICE AND PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DRUG, AND PROBABLY RELATED TO DEVICE AND PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 8183642 ↗

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