IN.PACT™ Admiral™ ADM05012008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169383586), received between Dec 13, 2018 and May 27, 2020 — 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.

• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT ADMIRAL DEB WAS USED TO TREAT THE POPLITEAL (R1). THE TARGET LESION WAS REVASCULARIZED USING A NON-MEDTRONIC DEVICE, SIX MONTHS POST INDEX PROCEDURE. THE TARGET LESION WAS REVASCULARIZED USING AN IN.PACT ADMIRAL PTA AND DES STENT, 23 MONTHS POST INDEX PROCEDURE. APPROXIMATELY 23 MONTHS LATER THE PATIENT SUFFERED 100% STENOSIS. THE EVENT WAS TREATED WITH PTA AND BMS STENTING OF THE TARGET LESION (R1), THE POPLITEAL.

  Patient problems: Stenosis

  MAUDE report 10091016 ↗
• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THE POPLITEAL (R1) WAS TREATED WITH AN IN.PACT ADMIRAL PTA. APPROXIMATELY 23 MONTHS LATER REVASCULARISATION WAS CARRIED OUT TO TREAT RESTENOSIS OF THE TARGET LESION, THE POPLITEAL. DURING THE REVASC, AN IN.PACT ADMIRAL PTA WAS USED AND THE PATIENT WAS ALSO TREATED WITH A DES.

  Patient problems: Stenosis

  MAUDE report 10050627 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT ADMIRAL PTA BALLOON CATHETER WAS USED TO TREAT THE POPLITEAL OF THE RIGHT LIMB. APPROX. 6 MONTHS POST INDEX PROCEDURE, RESTENOSIS OF TARGET LESION AT THE POPLITEAL ARTERY WAS REPORTED. IT WAS REPORTED THAT THROMBUS WAS PRESENT IN THE TARGET LESION. THE PATIENT WAS TREATED WITH MEDICATION AND REVASCULARIZATION OF THE TARGET LESION WAS CARRIED OUT USING A PTA. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND PACLITAXEL MEDICATION AND NOT RELATED TO THE PROCEDURE. SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND PACLITAXEL MEDICATION AND NOT RELATED TO THE PROCEDURE. THE PATIENT RECOVERED. A DISSECTION OCCURRED DURING THE INDEX PROCEDURE. THIS WAS NOT TREATED WITH PROVISIONAL STENTING.

  Patient problems: Stenosis; Thrombus

  MAUDE report 8159696 ↗

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