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In.Pact™ 018 IPU05008013PRecalls & reported problems

Medtronic, Inc. · DCB 018 IPU05008013P D5.0 L080 UL0130 · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000291396), received between Feb 20, 2023 and Feb 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

Device problems

  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 20, 2023Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE AN IN.PACT 018 BALLOON TO TREAT A FIBROUS CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. THERE WAS LITTLE TORTUOSITY. THERE WAS LITTLE CALCIFICATION. THERE WAS CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. THE DEVICE WAS PREPPED PER IFU. NO DAMAGE NOTED TO PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. A 5 COOK SHEATH FRENCH WAS USED. A NITREX 018 GUIDEWIRE WAS USED. NO EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT THERE WAS A PINHOLE LEAK AT 8 ATMS. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL BALLOONING WITH CHOCOLATE 5X40 AND THEN NEW DCB USED TO TREAT. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16403773 ↗

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

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page