IN.PACT™ AV IAV06004004PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000232825), received between Jun 21, 2023 and Aug 14, 2025 — classified as 1 death, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 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 VENOUS OUTFLOW. APPROXIMATELY 23 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT FOREARM RADIO-CEPHALIC FISTULA STENOSIS. LOW FLOW RATE NOTED AT HEMODIALYSIS VISIT. ADMITTED AS OUTPATIENT FOR FISTULAGRAM WITH INTENT TO TREAT. ANGIOGRAM AND ANGIOPLASTY PERFORMED WITH RESTORATION OF THRILL. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22804088 ↗
• InjuryAug 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 VENOUS OUTFLOW. APPROXIMATELY 23 MONTHS POST PROCEDURE PATIENT SUFFERED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MSSA) BACTEREMIA. SUBJECT ADMITTED TO HOSPITAL, TWO DAYS AFTER FISTULA REVISION, WITH FEVER AND POSITIVE BLOOD CULTURES FOR MSSA BACTEREMIA. STARTED ON CEFAZOLIN IV. PATIENT RECOVERED.

  Patient problems: Bacteremia; Fever

  MAUDE report 22803956 ↗
• InjuryJan 17, 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 VENOUS OUTFLOW. APPROXIMATELY 8 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS LEFT ARTERIOVENOUS FISTULA ANASTOMOSIS. DECREASING FLOWS AND PROLONGED BLEEDING AT LEFT FOREARM FISTULA. PREVIOUSLY TREATED WITH DCB. FISTULOGRAM WITH INTENT TO TREAT. TREATED WITH BALLOON ANGIOPLASTY. FLOWS IMPROVED. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stenosis

  MAUDE report 21179334 ↗
• InjuryJan 8, 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. ANOTHER TWO IN-PACT AV ACCESS DEVICES WERE USED LATE R. APPROXIMATELY 15 MONTHS POST PROCEDURE PATIENT SUFFERED RECURRENT STENOSIS OF ANASTOMOSIS AND INFLOW PORTION OF LEFT ARTERIOVENOUS FISTULA. RECURRENT MODERATE STENOSIS WITHIN INFLOW PORTION OF LEFT CIMINO FISTULA. BALLOON ANGIOPLASTY OF THE ARTERIOVENOUS ANASTO MOSIS AND INFLOW PORTION OF THE FISTULA. THIS WAS FOR THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21102609 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A IN.PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 1 MONTH POST PROCEDURE PATIENT SUFFERED  RESTENOSIS OF AV ANASTOMOSIS OF THE AVF. PATIENT UNDERWENT FISTULOGRAM TO LEFT CEPHALIC VEIN AV ANASTOMOSIS INDEX TARGET LESION, ANGIOPLASTY WAS PERFORMED WITH A MEDTRONIC DCB. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19094876 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A IN.PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 5 MONTHS POST PROCEDURE PATIENT SUFFERE D RECURRENT STENOSIS OF LEFT AV FISTULA. PATIENT UNDERWENT REVISION OF LEFT CEPHALIC AND AV ANASTOMOSIS WITH RECURRING STENOSIS. MULTI-BALLOON ANGIOPLASTY WAS PERFORMED. THIS PROCEDURE WAS FOR THE TARGET LESION. MEDTRONIC DCB WAS USED DURING THIS PROCEDURE. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18815796 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A IN.PACT AV ACCESS WAS USED TO TREAT A VENOUS OUTFLOW VEIN OF THE LEFT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS. IT WAS REPORTED THAT THERE WAS DECREASING FLOW AND PROLONGED BLEEDING AT LEFT FOREARM FISTULA. PREVIOUSLY TREATED WITH DCB. FISTULOGRAM PERFORMED. THE EVENT WAS TREATED WITH BALLOON ANGIOPLASTY. FLOW IMPROVED THROUGH FISTULA. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stenosis

  MAUDE report 18316470 ↗
• DeathJun 21, 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 VENOUS OUTFLOW OF THE LEFT ARM. APPROXIMATELY 9 DAYS POST PROCEDURE THE PATIENT DIED DUE TO AN UNKNOWN CAUSE.

  Patient problems: Insufficient Information

  MAUDE report 17169105 ↗

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