In.Pact™ 018 IPU04010013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000291242), received between Sep 2, 2025 and Mar 2, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT 018 BALLOON WAS USED TO TREAT THE PATIENT. POST PROCEDURE PATIENT SUFFERED STENOSIS OF LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. PATIENT PRESENTED TO HOSPITAL WITH WORSENING LEFT GREAT TOE PAIN. TOE WAS AMPUTATED. ON ULTRASOUND, PATIENT WAS FOUND TO HAVE SEVERE STENOSIS IN ORIGIN OF DVA TRACH. PATIENT UNDERWENT LEFT LOWER EXTREMITY ANGIOGRAM, BALLOON ANGIOPLASTY OF THE LEFT POSTERIOR TIBIAL ARTERY AND TIBIOPERONEAL TRUNK AND STENTING OF THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. TARGET LESION OF INDEX PROCEDURE WAS LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. THE EVENT WAS TREATED WITH SURGICAL PROCEDURE. PATIENT RECOVERED.

  Patient problems: Pain; Stenosis

  MAUDE report 24479722 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN. PACT 018 BALLOON WAS USED TO TREAT THE PATIENT. POST PROCEDURE PATIENT SUFFERED ISCHEMIC TOE STENOSIS OF LEFT LOWER EXTREMITY. SUBJECT PRESENTED TO EMERGENCY DEPARTMENT WITH LEFT TOE PAIN AND DISCOLORATION. PATIENT ADMITTED TO VASCULAR SURGERY. PATIENT UNDERWENT LEFT LOWER EXTREMITY ANGIOGRAM, BALLOON ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY AND SELECTIVE CATHETERIZATION OF POPLITEAL ARTERY. PATIENT WAS HOSPITALIZED FOR APPROXIMATELY 5 WEEKS AND DISCHARGED. PATIENT UNDERWENT AMPUTATION OF LEFT TOE, DEEP VEIN ARTERIALIZATION, BALLOON ANGIOPLASTY AND STENTING OF THE SUPERFICIAL FEMORAL ARTERY. PATIENT RECOVERED.

  Patient problems: Ischemia; Pain; Skin Discoloration; Stenosis

  MAUDE report 23959997 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT 018 BALLOON WAS USED TO TREAT THE PATIENT. POST PROCEDURE PATIENT SUFFERED SOFT TISSUE INFECTION. SUBJECT'S RIGHT GROIN WOUND OPENED AND HAD FIBRINOUS MATERIAL THAT IS ALSO MALODOROUS. ADMITTED TO HOSPITAL FOR INTRAVENOUS ANTIBIOTICS AND WOUND WASHOUT. WOUND WASHOUT AND DEBRIDEMENT PERFORMED. ON DAY OF DISCHARGE, PAIN WAS CONTROLLED ON ORAL PAIN MEDICATION. DISCHARGED TO SHORT TERM REHABILITATION WITH A 6-WEEK COURSE OF INTRAVENOUS ANTIBIOTICS. FOLLOW UP WITH VASCULAR SURGERY IN 2 WEEKS. PATIENT RECOVERED.

  Patient problems: Unspecified Infection

  MAUDE report 23955220 ↗
• MalfunctionSep 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID POPLITEAL ARTERY USING AN IN. PACT ADMIRAL 018 DRUG COATED BALLOON, THE BALLOON BURST BELOW RATED BURST PRESSURE ON THE FIRST INFLATION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND A DIFFERENT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931843 ↗

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