IN.PACT™ AV IAV08006008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000232658), received between Jan 9, 2024 and Apr 23, 2026 — classified as 19 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 19 most recent of 19 reports, 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 ↗
• 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 ↗
• InjuryAug 19, 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 CEPHALIC ARCH. APPROXIMATELY 4 MONTHS POST PROCEDURE PATIENT SUFFERED CEPHALIC ARCH STENOSIS AT ORIGINAL DRUG COATED BALLOON SITE. ROUTINE FISTULAGRAM LEFT ARM - CEPHALIC ARCH - ORIGINAL DRUG COATED BALLOON SITE GOOD THRILL THROUGHOUT THE FISTULA APPRECIATED PER CHART AFTER PROCEDURE. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION AND MEDICATION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22837111 ↗
• 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 CEPHALIC ARCH. ANOTHER IN.PACT AV ACCESS WAS LATER USED TO TREAT THE LEFT ARM. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED CEPHALIC ARCH STENOSIS AT ORIGINAL DRUG COATED BALLOON SITE. ROUTINE FISTULAGRAM LEFT ARM ARTERIOVENOUS FISTULA - CEPHALIC ARCH LESION - ORIGINAL DRUG COATED BALLOON SITE IMPROVED PATENCY NOTED AFTER PROCEDURE. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22805124 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FOUR IN.PACT AV ACCESS BALLOONS WERE USED TO TREAT THE LEFT ARM VENOUS OUTFLOW. APPROXIMATELY 20 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSES AT VENOUS OUTFLOW. ANGIOGRAPHY DEMONSTRATED MODERATE STENOSES WITHIN VENOUS OUTFLOW (TARGET LESION INVOLVED) ADJACENT TO PREVIOUSLY PLACED STENT ALONG WITH IN-STENT STENOSIS. BALLOON ANGIOPLASTY WAS PERFORMED WITH 6 MM AND 7 MM BALLOONS (NON-DRUG COATED BALLOON). PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22369036 ↗
• InjuryJun 19, 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. APPROXIMATELY 16 MONTHS POST PROCEDURE PATIENT SUFFERED MULTI-FOCAL OUTFLOW VENOUS STENOSES AND CENTRAL VEIN STENOSES OCCURRING AT ARTERIOVENOUS FISTULA SITE. MAINTENANCE ON HEMODIALYSIS WITH RIGHT UPPER EXTREMITY BRACHIAL-BASILIC ARTERIOVENOUS FISTULA. BALLOON ANGIOPLASTY WAS PERFORMED FROM THE PROXIMAL FISTULA JUST BELOW THE BEGINNING OF THE STENTED PORTION WITH A 7 MM X 15 CM ANGIOPLASTY BALLOON. NO DRUG COATED BALLOON WAS USED. VENOPLASTY WAS PERFORMED THROUGHOUT THE FISTULA TO THE STENTED PORTION AND THE TRANSITION OF THE RIGHT AXILLARY/SUBCLAVIAN VEIN (PART OF CENTRAL VEIN). PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 22288962 ↗
• InjuryApr 3, 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 9 MONTHS POST PROCEDURE PATIENT SUFFER ED DIFFICULT CANNULATION DUE TO DYSFUNCTIONAL ARTERIOVENOUS FISTULA. DIFFICULT CANNULATION IN THE LEFT ARM BRACHIAL CEPHALIC ARTERIOVENOUS FISTULA. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 21761577 ↗
• InjurySep 5, 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 CENTRAL VEIN . APPROXIMATELY 3 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBOSIS OF THE BRACHIOBASILIC FISTULA TREATED WITH BALLOON ANGIOPLASTY. STENOSIS WAS LOCATED WITHIN THE VENOUS OUTFLOW, LOCATED CENTRALLY AT THE BRACHIOCEPHALIC/SVC JUNCTION. PATIENT RECOVERED

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 20146514 ↗
• 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 CEPHALIC ARCH. TWO IN.PACT AV ACCESS WERE USED TO TREAT THE CEPHALIC ARCH. APPROXIMATELY 6 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOSIS CEPHALIC ARCH. RESTENOSIS AVF AT INDEX TARGET LESION TREATED WITH STENT GRAFT AND MEDTRONIC DCB FOR RECALCITRANT STENOSIS WITH IMPROVEMENT POST PTA AND STENTING. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19094834 ↗
• InjuryApr 10, 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 CEPHALIC ARCH. APPROXIMATELY 5 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOTIC AVF CEPHALIC ARCH. A FISTULOGRAM WAS PERFORMED WHICH DEMONSTRATED STENOSIS OF THE CEPHALIC ARCH. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED USING A 7X6MM CONQUEST BALLOON. SEQUENTIAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING A 10X80MM DORADO FOR BETTER TRANSITION FOLLOWED BY 9X80MM MEDTRONIC DCB. THEN TREATED WITH THE 7X60 CONQUEST FOLLOWED BY A 8X40 MEDTRONIC DCB. NO COMPLICATIONS. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19079471 ↗
• InjuryJan 9, 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 RIGHT ARM CENTRAL VEIN. APPROXIMATELY 4 MONTHS POST PROCEDURE PATIENT REQUIRED RE-INTERVENTION. PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18480777 ↗

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