IN.PACT™ AV IAV12004008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000232719), received between Nov 29, 2022 and Feb 18, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 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 RIGHT ARM CENTRAL VEIN. ANOTHER IN. PACT AV ACCESS WAS LATER USED TO TREAT THE RIGHT ARM. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED CENTRAL VEIN RESTENOSIS OF THE TARGET LESION. ANGIOGRAM PERFORMED DUE TO SWELLING REQUIRING ANGIOPLASTY OF RE-STENOTIC TARGET LESION OF THE RIGHT ARM. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21403073 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN INPACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM CENTRAL VEIN. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED RIGHT ARM CENTRAL VEIN RESTENOSIS OF THE TARGET LESION. RIGHT UPPER ARM ANGIOGRAM AND ANGIOPLASTY OF THE CENTRAL VEIN RESTENOSIS OF THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21322225 ↗
• InjuryNov 7, 2024Adverse 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 BRACHIOCEPHALIC VEIN. ANOTHER IN.PACT AV ACCESS WAS LATER USED TO TREAT THE LEFT ARM BRACHIOCEPHALIC VEIN. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED RECURRENT STENOSIS OF LEFT BRACHIOCEPHALIC VEIN. PATIENT UNDERWENT REVISION OF LEFT BRACHIOCEPHALIC VEIN WITH RECURRING LEFT HAND SWELLING. A BALLOON ANGIOPLASTY WAS PERFORMED. THIS PROCEDURE WAS FOR THE TARGET REGION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 20629311 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN. PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM. ANOTHER IN. PACT AV ACCESS WAS LATER USED TO TREAT THE LEFT ARM. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED RESTENOSIS OF SUBCLAVIAN VEIN. PATIENT HAD AN AVF DUPLEX WHICH NOTED EVIDENCE OF STENOSIS. PHYSICIAN NOTED AT VISIT THAT PATIENT WILL UNDERGO REPEAT FISTULOGRAM AND ANGIOPLASTY IN THREE MONTHS TO REDUCE THE RISK OF AV FISTULA THROMBOSIS. PATIENT UNDERWENT ANGIOPLASTY CITING PREVIOUS PULSATILITY. DURING THE PROCEDURE, THE FISTULOGRAM SHOWED CENTRAL STENOSIS IN THE SUBCLAVIAN VEIN (INDEX PROCEDURE TARGET LESION). EXCELLENT THRILL AND REDUCED PULSATILITY WAS NOTED POST-OP. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 20599138 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IMPACT AV ACCESS WAS USED TO TREAT THE LEFT ARM BRACHIOCEPHALIC. APPROXIMATELY 9 MONTHS POST PROCEDURE PATIENT SUFFERED RECURRENT STENOSIS OF LEFT SUBCLAVIAN VEIN. PATIENT UNDERWENT REVISION OF LEFT SUBCLAVIAN VEIN WITH RECURRING LEFT-HAND SWELLING. A BALLOON ANGIOPLASTY WAS PERFORMED. THIS PROCEDURE WAS FOR A NON-TARGET LESION. MEDTRONIC DCB WAS USED DURING THIS PROCEDURE AND THE INDEX TARGET LESION WAS NOT TREATED DURING THIS PROCEDURE. PATIENT RECOVERED. THE CEC ASSESSED THE EVENT AS RELATED TO THE TARGET LESION.

  Patient problems: Stenosis

  MAUDE report 19476987 ↗
• InjuryDec 1, 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 THE LEFT BRACHIOCEPHALIC VEIN. APPROXIMATELY 6 MONTHS POST PROCEDURE PATIENT SUFFERED RECURRENT STENOSIS, LEFT HAND SWELLING. THE EVENT WAS TREATED WITH A BALLOON ANGIOPLASTY IN THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Stenosis; Swelling/ Edema

  MAUDE report 18244483 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IMPACT AV ACCESS BALLOON WAS USED TO TREAT THE A LESION IN THE RT INNOMINATE. IT WAS REPORTED THAT A DISSECTION CAUSED BY THE IMPACT AV ACCESS BALLOON OCCURRED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 16829796 ↗
• InjuryDec 20, 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 CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 13 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM RIGHT MODERATE CEPHALIC ARCH AND SUBCLAVIAN STENOSIS. IT WAS NOTED THAT THE PATIENT HAD AN ANEURYSMAL DISTAL PORTION OF THE AV FISTULA AND PULSATILE THRILL WAS NOTED OVER THE RIGHT AVF WITH PAIN ON THE PROXIMAL PORTION DURING DIALYSIS. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION.

  Patient problems: Aneurysm; Pain; Stenosis

  MAUDE report 16012558 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM RIGHT ARM CEPHALIC VEIN RESTENOSIS. THE PATIENT COMPLAINED OF PAIN ON THE PROXIMAL PORTION OF THE AVF WHICH WAS PULSATILE ON EXAMINATION. THE SPONSOR COMMENTED THAT THE RESTENOSIS OCCURRED IN THE TARGET INDEX LESION. THE EVENT WAS TREATED WITH A TARGET LESION REVASCULARIZATION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Pain; Stenosis

  MAUDE report 15876059 ↗

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