IN.PACT™ Admiral™ ADM04015008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169576308), received between Aug 22, 2019 and Sep 3, 2019 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 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 THE LEFT DISTAL SFA. APPROXIMATELY 5 MONTHS POST PROCEDURE, PATIENT SUFFERED CRITICAL LIMB ISCHEMIA WHICH WAS TREATED WITH REVASCULARIZATION OF THE TARGET LESION USING PTA BALLOON AND STENT. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 8955503 ↗
• InjurySep 2, 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 THE LEFT PROXIMAL SFA. APPROXIMATELY 11 MONTHS POST PROCEDURE, PATIENT SUFFERED CRITICAL LIMB ISCHEMIA WITH REVASCULARIZATION USING AN INPACT ADMIRAL DCB BALLOON CATHETER. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE AND PACLITAXEL.

  Patient problems: Occlusion

  MAUDE report 8953411 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCB WERE USED TO TREAT THE LEFT PROX, MID AND DISTAL SFA. DURING A REVASCULARISATION PROCEDURE THE PATIENT WAS TREATED WITH AN INPACT ADMIRAL DCB. APPROXIMATELY 11 MONTHS POST PROCEDURE THE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA REPORTED AS PROBABLY RELATED TO THE TARGET LESION AND WAS TREATED WITH A PTA THE SAME DAY. THE EVENT IS RESOLVED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 8939871 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCB WERE USED TO TREAT THE LEFT PROX, MID AND DISTAL SFA. DURING A REAVASCULARIZATION PROCEDURE THE PATIENT WAS TREATED WITH AN IN PACT ADMIRAL PTA. APPROXIMATELY 11.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA REPORTED AS PROBABLY RELATED TO THE TARGET LESION AND WAS TREATED WITH A IN PACT ADMIRAL DCB. THE EVENT IS RESOLVED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 8939816 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCB WERE USED TO TREAT THE LEFT PROX, MID AND DISTAL SFA. APPROXIMATELY 3.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA REPORTED AS PROBABLY RELATED TO THE TARGET LESION AND WAS TREATED WITH A PTA. THE EVENT IS RESOLVED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 8939670 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCB WERE USED TO TREAT THE LEFT PROX, MID AND DISTAL SFA. APPROXIMATELY 8.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA REPORTED AS PROBABLY RELATED TO THE TARGET LESION AND WAS TREATED WITH AN INPACT ADMIRAL DCB. THE EVENT IS RESOLVED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 8938957 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCB WERE USED TO TREAT THE LEFT PROX, MID AND DISTAL SFA. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA REPORTED AS PROBABLY RELATED TO THE TARGET LESION AND WAS TREATED WITH A PTA. THE EVENT IS RESOLVED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL. (UPDATES (B)(6) 2019 ALSO REVIEWED).

  Patient problems: Injury

  MAUDE report 8938779 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCB WERE USED TO TREAT THE LEFT PROX, MID AND DISTAL SFA. APPROXIMATELY 5 WEEKS POST PROCEDURE THE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA REPORTED AS PROBABLY RELATED TO THE TARGET LESION AND WAS TREATED WITH A PTA. THE EVENT IS RESOLVED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury; Patient Problem/Medical Problem

  MAUDE report 8934905 ↗
• InjuryAug 22, 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 MID SFA. APPROXIMATELY 1 YEAR POST INDEX PROCEDURE THE PATIENT UNDERWENT TARGET LESION REVASCULARISATION.

  Patient problems: Injury

  MAUDE report 8920730 ↗

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