IN.PACT™ AV IAV10004008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000232702), received between Aug 22, 2022 and Dec 14, 2025 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED ARTERIOVENOUS FISTULAGRAM WITH SUBCLAVIAN VEIN STENOSIS. PATIENT WAS EVALUATED FOR ANGIOGRAM DUE TO HIGH VENOUS PRESSURES LEADING TO DYSFUNCTIONAL ARTERIOVENOUS FISTULAGRAM. STENOSIS IN SUBCLAVIAN VEIN WAS DISCOVERED, AND PERCUTANEOUS INTERVENTION WAS DONE. PATIENT RECOVERED.

  Patient problems: High Blood Pressure/ Hypertension; Stenosis

  MAUDE report 23799559 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 14 MONTHS POST PROCEDURE PATIENT SUFFERED VENOUS HYPERTENSION. HIGH VENOUS PRESSURES DURING AND PROLONGED BLEEDING AFTER DIALYSIS SESSIONS DUE TO STENOSIS IN THE CENTRAL VEIN WHICH IS THE TARGET LESION. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Stenosis

  MAUDE report 21374223 ↗
• InjuryMar 30, 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 CENTRAL VEIN OF THE LEFT ARM. APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM LEFT CEPHALIC ARCH STENOSIS. IT WAS NOTED THAT THE PATIENT HAD HIGH VENOUS PRESSURE WITH PAIN IN THE SHOULDER WITH PROLONGED BLEEDING. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE VENOUS OUTFLOW AND CEPHALIC ARCH. THE PATIENT RECOVERED. THE CEC ADJUDICATED THE EVENT AS RELATED TO THE DEVICE. THE CEC COMMENTED THAT THE EVENT INVOLVED THE TARGET LESION AND THE CLINICAL SYMPTOMS WERE WITH TARGET LESION STENOSIS, HOWEVER THERE WAS LESS THAN 50% STENOSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Stenosis

  MAUDE report 16642443 ↗
• InjuryFeb 20, 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 CENTRAL VEIN OF THE LEFT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM LEFT ARM ARTERIOVENOUS FISTULA (AVF) PSEUDOANEURYSM. BLEEDING WAS ALSO NOTED IN THE PREVIOUSLY ULCERATED SITE IN THE LEFT AVF. THE EVENT WAS TREATED WITH A SURGICAL REPAIR OF THE ANEURYSM IN A NON TARGET LESION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 16402514 ↗
• InjuryFeb 14, 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 IN CANNULATION ZONE OF THE LEFT ARM. APPROXIMATELY 16 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE AV FISTULA. IT WAS NOTED THAT THE PATIENT HAD A TANDEM RESTENOTIC LESION AT THE CANNULATION ZONE AND CEPHALIC ARCH. THE PATIENT WAS TREATED WITH A AN ANGIOPLASTY OF THE CANNULATION ZONE AND CEPHALIC ARCH OF THE LEFT ARM. NO DRUG COATED BALLOON OR STENT WAS USED. RESIDUAL STENOSIS WAS NOT NOTED POST PROCEDURE. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Stenosis

  MAUDE report 16370257 ↗
• InjuryAug 22, 2022Adverse 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 CENTRAL VEIN OF THE LEFT ARM. APPROXIMATELY 4 WEEKS POST PROCEDURE THE PATIENT SUFFERED FROM LEFT SUBCLAVIAN VEIN STENOSIS. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE TARGET LESION USING A BALLOON ANGIOPLASTY. THE PATIENT RECOVERED WITH SEQUELAE. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE SPONSOR COMMENTED THAT THE PERCUTANEOUS INTERVENTION WAS PERFORMED TO TREAT THE TARGET LESION.

  Patient problems: Stenosis

  MAUDE report 15263898 ↗

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