IN.PACT™ Admiral™ ADM06008008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169383234), received between Oct 30, 2018 and Sep 3, 2019 — classified as 1 death, 1 injury.

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.

• DeathSep 3, 2019Adverse 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 CATHETERS WERE USED TO TREAT LESION IN THE LEFT PROXIMAL AND MID SFA. APPROXIMATELY 6 MONTHS POST PROCEDURE, PATIENT DIED. CAUSE OF DEATH IS UNEXPLAINED. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Death

  MAUDE report 8954844 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, AN IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER WAS USED TO TREAT THE DISTAL SFA OF THE RIGHT LIMB. APPROXIMATELY 6 MONTHS POST PROCEDURE, PATIENT SUFFERED RIGHT SFA OCCLUSION (TL) AND WAS TREATED WITH PTA AND IMPLANTATION OF STENT. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO PROCEDURE OR PACLITAXEL BUT POSSIBLY RELATED TO THE DEVICE. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO PROCEDURE OR PACLITAXEL.

  Patient problems: Occlusion

  MAUDE report 8021750 ↗

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