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IN.PACT™ AV IAV09006008PRecalls & reported problems

Medtronic, Inc. · DCB IAV09006008P 09.00 L060 UL0800 US · Class 3

All models of IN.PACT AV (18)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000232689), received between Nov 30, 2020 and Nov 30, 2020 — classified as 1 injury.

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 (P190008); 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

  • Burst Container or Vessel1
  • Detachment of Device or Device Component1

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.

  • InjuryNov 30, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A INPACT ADMIRAL AV ACCESS DRUG ELUTING BALLOON TO TREAT THE CEPHALIC VEIN IN A PATIENT. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE (ENCORE) THERE WAS NO DAMAGE TO PACKAGING, AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS PREPPED AS PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FOR WAS USED. IT WAS REPORTED THAT THE BALLOON BURST AT 12 ATMS DURING BALLOON INFLATION. ALL FRAGMENTS WERE RECEIVED, 6 FRENCH SHEATH USED, PARTIAL BALLOON FRAGMENT DETACHED WAS SNARED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10919257 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P190008. One submission often covers many models, so check the product and lot details in each record.

  • Z-1043-2022 · Mar 23, 2022 · Open, Classified
    Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only

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Sources and updates

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