IN.PACT™ AV IAV08008013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000233181), received between Jul 19, 2023 and Jul 19, 2023 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE ANASTOMOSIS OF THE RIGHT ARM. APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE ARTERIOVENOUS GRAFT. THE STENOSIS OF THE VENOUS ANASTOMOSIS WAS NOTED AT A FOLLOW UP OFFICE VISIT AND A SHUNTAGRAM WAS SCHEDULED. IT WAS STATED THAT THE VENOUS ANASTOMOSIS WAS THE PRIMARY LESION FROM THE ENROLLMENT PROCEDURE. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE TARGET LESION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17348328 ↗

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