IN.PACT AVRecalls & reported problems across all models

We found 18 models of IN.PACT AV by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 119 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2020 and Apr 23, 2026 — classified as 1 death, 111 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

IN.PACT AV recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 23, 2022Open, Classified

   Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

   Z-1043-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported IN.PACT AV problems

IN.PACT AV models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IN.PACT™ AV IAV06008008P

  Drug-coated peripheral transluminal angioplasty catheter
  1 recall1 report
• IN.PACT™ AV IAV08004008P

  Drug-coated peripheral transluminal angioplasty catheter
  21 reports
• IN.PACT™ AV IAV08006008P

  Drug-coated peripheral transluminal angioplasty catheter
  19 reports
• IN.PACT™ AV IAV08008008P

  Drug-coated peripheral transluminal angioplasty catheter
  11 reports
• IN.PACT™ AV IAV09008008P

  Drug-coated peripheral transluminal angioplasty catheter
  11 reports
• IN.PACT™ AV IAV12004008P

  Drug-coated peripheral transluminal angioplasty catheter
  9 reports
• IN.PACT™ AV IAV06006008P

  Drug-coated peripheral transluminal angioplasty catheter
  8 reports
• IN.PACT™ AV IAV09004008P

  Drug-coated peripheral transluminal angioplasty catheter
  8 reports
• IN.PACT™ AV IAV06004004P

  Drug-coated peripheral transluminal angioplasty catheter
  1 death8 reports
• IN.PACT™ AV IAV07004008P

  Drug-coated peripheral transluminal angioplasty catheter
  6 reports
• IN.PACT™ AV IAV10004008P

  Drug-coated peripheral transluminal angioplasty catheter
  6 reports
• IN.PACT™ AV IAV07004004P

  Drug-coated peripheral transluminal angioplasty catheter
  5 reports
• IN.PACT™ AV IAV05008008P

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• IN.PACT™ AV IAV07006008P

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• IN.PACT™ AV IAV09006008P

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• IN.PACT™ AV IAV05004004P

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• IN.PACT™ AV IAV09004004P

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• IN.PACT™ AV IAV08008013P

  Drug-coated peripheral transluminal angioplasty catheter
  1 report

Recent IN.PACT AV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE IN.PACT AV ACCESS WAS USED TO TREAT THE RIGHT CENTRAL VEIN. APPROXIMATELY 8 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS OF RIGHT UPPER EXTREMITY ARTERIOVENOUS FISTULA. INITIAL FISTULAGRAM SHOWED STENOSES IN STENT IN VENOUS OUTFLOW AND IN THE BRACHIOCEPHALIC/SUPERIOR VENA CAVA JUNCTION. ANGIOPLASTY OF THE VENOUS FLOW STENT WAS DONE WITH A 7 MM AND 9 MM BALLOON. ANGIOPLASTY OF THE BRACHIOCEPHALIC/SUPERIOR VENA CAVA WAS PERFORMED WITH A 9 MM BALLOON. FINAL FISTULAGRAM SHOWS IMPROVEMENT IN STENOTIC REGIONS. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 24973763 ↗
• 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 ↗
• InjuryOct 21, 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 ANASTOMOSIS. APPROXIMATELY 2 YEARS 10 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS OF JUXTA-ANASTOMOSIS. PROLONGED BLEEDING AND DECREASED FLOW DURING AND AFTER HD TREATMENTS. 7MM DIAMETER BALLOON USED TO PERFORM ANGIOPLASTY. POST-INTERVENTION GRAFTOGRAM DEMONSTRATED NO STENOSIS. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Reduced Blood Flow; Stenosis

  MAUDE report 23347845 ↗
• MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel

  PHYSICN WAS ATTEMPTING TO USE IN.PACT AV BALLOON TO TREAT PLAQUE/SOFT TISSUE 40MM LESION IN PATIENTS RIGHT AVF ANASTOMOTIC REGION. MILD TORTUOSITY WAS REPORTED AND A 6FR SHEATH AND  035, 150 CM NON-MEDTRONIC GUIDEWIRE WAS USED. IT WAS REPORTED A PIN HOLE BALLOON BURST OCCURRED  AT 8ATM. THE BALLOON WAS COLLECTED DUE TO DIFFICULTY IN INFLATION, AND THE SAME SIZEOF THE SAME PRODUCT WAS USED AND IT WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050662 ↗
• MalfunctionSep 8, 2025Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE IN.PACT AV BALLOON TO TREAT PLAQUE LESION IN PATIENT LEFT BASILIC VEIN. THE PRODUCT WAS PREPARED ACCORDING TO THE IFU. IT WAS REPORTED THAT A BALLOON BURST OCCURED DURING BALLOON INFALTION AT NOMINAL PRESSURE. THE EVENT OCCURRED AFTER THE DEVICE WAS EXPANDED BY APPROXIMATELY 1 MINUTE AND 30 SECONDS, SO IT WAS DETERMINED THAT THE DRUG HAD MIGRATED TO THE BLOOD VESSEL WALL. THE PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991472 ↗
• MalfunctionSep 3, 2025Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE IN.PACT AV BALLON TO TREAT PATIENT'S CEPHALIC VEIN. A 6FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE WAS USED. THE DEVICE WAS PREPPED PER IFU AND SYRINGE WAS USED TO INFLATE THE BALLOON. IT WAS REPORTED DURING FIRST INFALTION A BALLOON BURST OCCURRED AND EXTENDED AT NOMINAL PRESSURE OF 8 ATMOSPHERE. RESISTANCE OCCURED DURING DELIVERY. THE BALLOON WAS REMOVED. NO PATIENT INJURY REPORTED.BUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952354 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW, BRACHIOCEPHALIC/SUPERIOR VENA CAVA (SVC) STENT AND THE CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE ARTERIOVENOUS FISTULA (AVF). A FISTULOGRAM WAS PERFORMED WHICH SHOWED RESTENOSIS OF THE VENOUS OUTFLOW, THE INDEX LESION. THE EVENT WAS TREATED WITH MEDICATION AND A PERCUTANEOUS INTERVENTION USING A DCB OF THE VENOUS OUTFLOW AND IN CANNULATION ZONE OF THE RIGHT ARM. THERE WAS COMPLETE RESOLUTION OF THE STENOSIS AND NO IMMEDIATE COMPLICATIONS WERE NOTED. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 22872606 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW, BRACHIOCEPHALIC/SVC STENT AND THE CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 6 MONTHS POST PROCEDURE THE PATIENT SUFFERED VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE PATIENT PRESENTED FOR A ROUTINE FISTULOGRAM WHICH SHOWED 60% RESTENOSIS IN THE INDEX LESION. THE PATIENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE IN CANNULATION ZONE, CENTRAL VEIN AND VENOUS OUTFLOW OF THE RIGHT ARM USING NON MEDTRONIC BALLOONS. THE PATIENT WAS ALSO TREATED WITH MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 22872140 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW, BRACHIOCEPHALIC/SUPERIOR VENA CAVA (SVC) STENT AND THE CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE RESTENOSIS IN THE INDEX LESION WAS SUCCESSFULLY TREATED WITH A TARGET LESION REVASCULARIZATION USING A PLAIN BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. THE SVC STENT, CENTRAL VEIN AND VENOUS OUTFLOW WERE TREATED DURING THE REVA SCULARIZATION. THE PATIENT WAS ALSO TREATED WITH MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 22870483 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS BALLOONS WERE USED TO TREAT THE VENOUS OUTFLOW, BRACHIOCEPHALIC/SVC STENT, CEPHALIC ARCH. APPROXIMATELY 14 MONTHS POST PROCEDURE PATIENT SUFFERED SCV IN STENT RESTENOSIS OF THE AVF. SVC IN STENT RESTENOSIS (INDEX LESION) SUCCESSFULLY TREATED WITH 12MM DRUG COATED BALLOON ANGIOPLASTY WITH NEAR COMPLETE RESOLUTION. NO IMMEDIATE COMPLICATIONS, DISCHARGED HOME SAME DAY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22870447 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW, BRACHIOCEPHALIC/SUPERIOR VENA CAVA (SVC) STENT AND THE CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 11 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE PATIENT PRESENTED FOR A ROUTINE FISTULOGRAM. IMAGING SHOWED 50% RESTENOSIS OF THE VENOUS OUTFLOW (TARGET LESION). THE SPONSOR COMMENTED THAT THERE WAS TARGET LESION RESTENOSIS. THE EVENT WAS SUCCESSFULLY TREATED WITH A PLAIN BALLOON AND DRUG COATED BALLOON ANGIOPLASTY USING NON MDT DEVICES. THERE WERE NO IMMEDIATE COMPLICATIONS NOTED. THE PATIENT WAS ALSO TREATED WITH MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 22862151 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW, BRACHIOCEPHALIC/SUPERIOR VENA CAVA (SVC) STENT AND THE CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 6 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM CENTRAL VEIN RESTENOSIS OF THE AVF. THE PATIENT PRESENTED FOR A ROUTINE FISTULOGRAM WHICH SHOWED RESTENOSIS IN THE CENTRAL VEIN (NON-INDEX LESION). THE EVENT WAS SUCCESSFULLY TREATED WITH A HIGH PRESSURE AND PLAIN BALLOON ANGIOPLASTY. DURING THE PERCUTANEOUS INTERVENTION, THE IN-CANNULATION ZONE, CENTRAL VEIN AND VENOUS OUTFLOW OF THE RIGHT ARM WERE ALSO TREATED USING NON-MEDTRONIC BALLOONS. THE PATIENT WAS ALSO TREATED WITH MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 22861575 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS WERE USED TO TREAT THE RIGHT ARM. APPROXIMATELY 14 MONTHS POST PROCEDURE PATIENT SUFFERED VENOUS OUTFLOW RESTENOSIS OF THE AVF. PATIENT PRESENTED FOR ROUTINE FISTULOGRAM. ANGIOGRAPHY SHOWED VENOUS OUTFLOW (INDEX LESION) RESTENOSIS. SUCCESSFULLY TREATED WITH 8MM DRUG COATED BALLOON ANGIOPLASTY WITH FULL RESOLUTION. NO IMMEDIATE COMPLICATIONS. DISCHARGED HOME SAME DAY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22861299 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN. PACT AV ACCESS BALLOONS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW, BRACHIOCEPHALIC/SVC STENT, RIGHT ARM CEPHALIC ARCH. APPROXIMATELY 26 MONTHS POST PROCEDURE PATIENT SUFFERED VENOUS OUTFLOW RESTENOSIS OF THE AV FISTULA. SUBJECT PRESENTED FOR ROUTINE DIALYSIS ACCESS. ANGIOGRAPHY SHOWED GREATER THAN 50 PERCENT STENOSIS IN THE VENOUS OUTFLOW (INDEX LESION). THIS WAS SUCCESSFULLY TREATED WITH PLAIN BALLOON ANGIOPLASTY. NO IMMEDIATE COMPLICATIONS. SUBJECT DISCHARGED HOME SAME DAY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22857853 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 4 IN.PACT AV ACCESS BALLOONS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW, BRACHIOCEPHALIC/SVC STENT, CEPHALIC ARCH. APPROXIMATELY 8 MONTHS POST PROCEDURE PATIENT SUFFERED CENTRAL VEIN RESTENOSIS OF THE ARTERIOVENOUS FISTULA. SUBJECT PRESENTED FOR ROUTINE FISTULOGRAM. ANGIOGRAPHY SHOWED RESTENOSIS OF THE CENTRAL VEIN. SUCCESSFULLY TREATED WITH DRUG-COATED BALLOON AND PLAIN BALLOON ANGIOPLASTY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22847449 ↗

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