IN.PACT™ Admiral™ ADM05008008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169383579), received between Apr 16, 2019 and Apr 17, 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.

• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCBS WERE USED TO TREAT THE LEFT PROXIMAL(L1) AND MID SFA(L2). DURING TREATMENT OF MID SFA(L2) GRADE C FLOW LIMITING DISSECTION OCCURRED AND WAS TREATED WITH STENTING WITH A BARE METAL STENT. IT WAS REPORTED THE DISSECTION WAS NOT RELATED TO THE TARGET LESION.

  Patient problems: Vascular Dissection

  MAUDE report 8521907 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCBS WERE USED TO TREAT THE LEFT PROXIMAL (L1) AND MID SFA(L2). APPROXIMATELY 6.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED RESTENOSIS OF THE LEFT SFA AND WAS TREATED WITH PTA AND STENTING OF THE MID SFA (L2). PATIENT RECOVERED. INVESTIGATOR ASSESSED THE EVENT AS UNLIKELY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE OR PACLITAXEL. SPONSOR ASSESSED THE EVENT AS UNLIKELY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 8518727 ↗

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