IN.PACT™ Admiral™ ADM05008013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169383623), received between Oct 5, 2018 and Jun 2, 2021 — classified as 1 death, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE RIGHT MID SFA AND TWO INPACT ADMIRAL BALLOON CATHETER WERE USED TO TREAT THE RIGHT DISTAL SFA. APPROXIMATELY 1 YEAR POST INDEX PROCEDURE THE PATIENT SUFFERED RIGHT SFA OCCLUSION. THE PATIENT WAS TREATED WITH PTA OF THE TARGET LESION. THE PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11920474 ↗
• InjuryJul 4, 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 LEFT PROX AND MID SFA (L-1). APPROX 11 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED LEFT SFA RESTENOSIS. THE PATIENT WAS TREATED WITH SURGICAL INTERVENTION AND PTA OF THE TARGET LESION (L-1). THE PATIENT RECOVERED. THE INVESTIGATOR AND 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 8762600 ↗
• DeathOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER WERE USED TO TREAT THE RIGHT MID TO DISTAL SFA. APPROXIMATELY 2 MONTH MOST PROCEDURE, PATIENT EXPIRED. PATIENT WAS TREATED IN ANOTHER HOSPITAL, EVENT DETAILS ARE UNKNOWN. INVESTIGATOR ASSESSED IS NOT REPORTED.

  Patient problems: Death

  MAUDE report 7938981 ↗