IN.PACT™ AV IAV09004008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000232672), received between Jul 18, 2023 and Aug 6, 2025 — classified as 8 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 6, 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. APPROXIMATELY 25 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBOSED ARTERIOVENOUS FISTULA. PATIENT UNDERWENT INTRAVENOUS UROGRAM PROCEDURE FOR THROMBECTOMY WITH DE-CLOT, BALLOON ANGIOPLASTY WHICH WAS TERMINATED DUE TO PATIENT GOING INTO VENTRICULAR TACHYCARDIA. VASCULAR SURGERY EXCHANGED THE PERMCATH OVERWIRE. ARTERIOVENOUS FISTULA WAS ABANDONED. PERMCATH PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND PATIENT WAS DISCHARGED HOME. RECURRENT STENOSIS AT INDEX LESION WITH THROMBOSIS OF ARTERIOVENOUS FISTULA. PATIENT RECOVERING.

  Patient problems: Stenosis; Tachycardia; Thrombosis/Thrombus

  MAUDE report 22733478 ↗
• InjuryAug 6, 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. APPROXIMATELY 24 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBOSIS OF ARTERIOVENOUS FISTULA. PATIENT ARRIVED TO THE EMERGENCY DEPARTMENT WITH A CLOTTED ARTERIOVENOUS FISTULA. UNDERWENT UNSUCCESSFUL CATHETER DIRECTED THROMBOLYSIS, MECHANICAL THROMBECTOMY, AND BALLOON ANGIOPLASTY OF THE OCCLUDED RIGHT BRACHIO-BASILIC ARTERIOVENOUS FISTULA. PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND A CODE BLUE WAS CALLED. THEY WERE CONVERTED BACK TO NORMAL SINUS RHYTHM AND ADMITTED TO THE INTENSIVE CARE UNIT FOR FURTHER MONITORING. PATIENT REMAINED STABLE AND WAS DISCHARGED HOME. RECURRENT STENOSIS WITH OCCLUSION REQUIRING DE-CLOT. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Stenosis; Tachycardia; Thrombosis/Thrombus

  MAUDE report 22724349 ↗
• InjuryFeb 6, 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. TWO MORE AV ACCESS BALLOONS WERE LATER USED. APPROXIMATELY 23 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBOSIS OF ARTERIOVENOUS FISTULA. THROMBOSIS PRESENT IN ARTERIOVENOUS FISTULA, INCLUDING TARGET LESION #1 CEPHALIC ARCH, LESION #2 CENTRAL VEIN, AND LESION #3 CEPHALIC ARCH. PRELIMINARY ULTRASOUND OF LEFT UPPER EXTREMITY BRACHIOCEPHALIC ARTERIOVENOUS FISTULA PERFORMED EXHIBITING SLOW FLOW AND CHRONIC CLOT IN CENTRAL CEPHALIC VENOUS OUTFLOW. 5-FRENCH ANGLED CATHETER USED TO CROSS OCCLUSION. COULD NOT CROSS OCCLUSION. DECISION MADE TO ABORT ATTEMPT AT THROMBECTOMY OR FISTULA SALVAGE. DECISION MADE FOR TUNNELED LINE PLACEMENT. LEFT INTERNAL JUGULAR TUNNELED DIALYSIS CATHETER SUCCESSFULLY PLACED. CATHETER READY FOR IMMEDIATE USE. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION INCLUDING CHRONIC DISEASES CRITERION IS NOT MET SINCE DIALYSIS LINE WAS PLACED ON DIALYSIS WAS RESUMED. PATIENT RECOVERED WITH SEQUELAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21321721 ↗
• InjuryJan 16, 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. APPROXIMATELY 5 MONTHS POST PROCEDURE PATIENT SUFFERED OUTFLOW STENOSIS OF RIGHT ARM ARTERIOVENOUS FISTULA. DUE TO COMPLAINTS OF RIGHT ARM PAIN THE PATIENT REQUIRED ANGIOGRAM AND ANGIOPLASTY OF OUTFLOW STENOSIS OF THE RIGHT ARM FISTULA; THIS WAS ALSO THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21170266 ↗
• InjuryNov 14, 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 RIGHT ARM. APPROXIMATELY 12 MONTHS POST PROCEDURE PATIENT SUFF ERED RESTENOSIS OF RIGHT AV FISTULA OUTFLOW VEIN. PATIENT UNDERWENT FISTULAGRAM TO FIND MODERATE STENOSIS IN OUTFLOW VEIN. A BALLOON WAS USED TO ANGIOPLASTY THE OUTFLOW VEIN. FOLLOW-UP IMAGING SHOWS WIDE PATENCY WITH NO SIGNIFICANT RESIDUAL STENOSIS REMAINING. THIS WAS FOR THE TARGET REGION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 20684915 ↗
• InjuryNov 8, 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 CEPHALIC VEIN OF THE LEFT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM RESTENOSIS OF THE LEFT SUBCLAVIAN VEIN. MILD CENTRAL JUXTA-CEPHALIC STENT STENOSIS WAS NOTED. A 8 X 40MM NON MDT BALLOON WAS USED TO ANGIOPLASTY THE CENTRAL JUXTA-CEPHALIC STENT STENOSIS. FOLLOW UP ANGIOGRAPHY DEMONSTRATED JUXTA-CEPHALIC STENT STENOSIS. THEREFORE A 9 X 40MM NON MDT BALLOON WAS USED TO ANGIOPLASTY THE LESION. A FOLLOW UP ANGIOGRAPHY DEMONSTRATED SIGNIFICANT LUMINAL GAIN. A 9 X 40MM IN.PACT AV ACCESS BALLOON CATHETER WAS THEN USED. THE SPONSORED COMMENTED THAT THIS WAS A TARGET LESION REVASCULARIZATION. THE PATIENT IS RECOVERING.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18090513 ↗
• InjuryNov 8, 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 CEPHALIC VEIN OF THE LEFT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM RESTENOSIS OF THE LEFT CEPHALIC VEIN IN THE ARTERIOVENOUS FISTULA. MULTIFOCAL MILD STENOTIC LESIONS IN THE MID CEPHALIC VEIN OUTFLOW TRACT WITH FOCUS OF MODERATE STENOSIS WERE NOTED. A 8 X 40MM NON MDT BALLOON WAS USED TO ANGIOPLASTY ALL OF THE MULTIFOCAL STENOTIC LESIONS IN THE MID CEPHALIC VEIN OUTFLOW TRACT. A FOLLOW UP ANGIOGRAPHY DEMONSTRATED SIGNIFICANT LUMINAL GAIN OF THE MILD MULTIFOCAL STENOSIS IN THE MID CEPHALIC VEIN OUTFLOW TRACT. HOWEVER THERE WAS STILL SIGNIFICANT STENOSIS AT THE FOCI OF MODERATE STENOSIS IN THE MID CEPHALIC VEIN OUTFLOW TRACT. THEREFORE A 9 X 40 MM NON MDT BALLOON WAS USED, FOLLOWED BY A 9 X 40MM IN.PACT AV ACCESS BALLOON. THE SPONSORED COMMENTED THAT THIS WAS A TARGET LESION REVASCULARIZATION. THE PATIENT IS RECOVERING.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18090441 ↗
• InjuryJul 18, 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 CEPHALIC VEIN OF THE LEFT ARM. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE LEFT CEPHALIC VEIN IN THE ARTERIOVENOUS FISTULA. A LEFT UPPER EXTREMITY BRACHIOCEPHALIC FISTULOGRAM WAS PERFORMED WHICH FOUND MULTIFOCAL MILD TO MODERATE STENOSIS THROUGHOUT THE CEPHALIC VEIN. THE CEPHALIC ARCH STENT, THE ARTERIAL ANASTOMOSIS AND THE CENTRAL VEINS WERE WIDELY PATENT. AN ANGIOPLASTY WAS SUCCESSFULLY PERFORMED IN THE LEFT CEPHALIC VEIN. THE PATIENT IS RECOVERING.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17341757 ↗

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