IN.PACT™ Admiral™ ADM06012008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169859968), received between Mar 25, 2019 and Oct 17, 2019 — classified as 1 death, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2019Adverse 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. SIX DAYS POST PROCEDURE, TWO IN.PACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE PROXIMAL SFA AND POPLITEAL OF THE LEFT LIMB. APPROXIMATELY 8 MONTHS POST PROCEDURES, PATIENT SUFFERED CRITICAL LIMB ISCHEMIA AND WAS TREATED WITH REVASCULARIZATION OF THE RIGHT DISTAL SFA (TARGET LESION) USING AN IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 9201189 ↗
• InjuryOct 10, 2019Adverse 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 RIGHT DISTAL SFA. SIX DAYS LATER, A STAGED PROCEDURE WAS CARRIED; 2 IN.PACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE LEFT PROXIMAL SFA AND POPLITEAL. APPROXIMATELY 4 MONTHS POST INDEX AND STAGED PROCEDURES, PATIENT SUFFERED CRITICAL LIMB ISCHEMIA. EVENT WAS TREATED WITH PTA BALLOON IN TARGET LESION RIGHT DISTAL SFA. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE AND PACLITAXEL. PATIENT RECOVERED.

  Patient problems: Injury

  MAUDE report 9174003 ↗
• DeathMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO INPACT ADMIRAL PTA BALLOON CATHETERS WERE USED TO TREAT THE RIGHT SFA. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED VENTRICULAR FIBRILLATION AND DIED SUDDEN CARDIAC DEATH ((B)(6) 2019). IT WAS REPORTED THAT THE DEATH WAS DUE TO VENTRICULAR FIBRILLATION.

  Patient problems: Death

  MAUDE report 8448285 ↗

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