In.Pact™ 018 IPU06008013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000291570), received between Apr 6, 2023 and Jan 19, 2026 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 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 TARGET LESION RIGHT SUPERFICIAL FEMORAL ARTERY STENOSIS. SUBJECT HAD FOLLOW-UP ULTRASOUND WITH LOWERED ANKLE BRACHIAL INDEX. VASCULAR SURGEON ORDERED COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) TO EVALUATE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) STENTS FOR IN STENT RESTENOSIS. CTA SHOWED PATENT STENT BUT SEVERE STENOSIS DISTAL TO RIGHT-SFA STENT. SUBJECT HAD ANGIOGRAM AND INTERVENTION DONE WITH LITHOTRIPSY AND 2 BOSTON DRUG COATED BALLOONS TO TREAT SFA. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 24109137 ↗
• MalfunctionApr 6, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN IN.PACT BALLOON WAS USED TO TREAT A PLAQUE LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY. STENOSIS WAS CTO (CHRONIC TOTAL OCCLUSION-100%). NO DEGREE OF TORTUOSITY. NO DEGREE OF CALCIFICATION. 6FR DESTINATION SHEATH FRENCH SIZE AND BRAND WAS USED. SPIDER SPD2-US-04-320 WAS USED. BALLOON INFLATED WITH A BARD INFLATION DEVICE. 50/50 INFLATION FLUID WAS USED. DEVICE PREPPED PER IFU.  THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE NOT USED.  IT WAS REPORTED THAT THERE WAS A PINHOLE BURST DURING INFLATION AT 10ATMS ON THE SECOND INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. PROCEDURE COMPLETED BY OPENING A NEW DRUG COATED BALLOON. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687643 ↗

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