IN.PACT™ AV IAV06006008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000232573), received between Sep 28, 2022 and Sep 15, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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.

• 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 ↗
• 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 IN CANNULATION ZONE. APPROXIMATELY 20 MONTHS POST PROCEDURE PATIENT SUFFERED JUXTA ANASTOMOSIS RESTENOSIS OF THE AV FISTULA. SUBJECT PRESENTED FOR ROUTINE DIALYSIS ACCESS WITH NO REPORTS OF ISSUES WITH DIALYSIS. FISTULOGRAM SHOWED A 90% RESTENOSIS OF THE JUXTA ANASTOMOSIS. TREATED WITH PLAIN BALLOON ANGIOPLASTY. NO IMMEDIATE COMPLICATIONS, SUBJECT DISCHARGED HOME SAME DAY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18815575 ↗
• InjurySep 20, 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 WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH TWO IN.PACT AV ACCESS BALLOON AND TWO NON MDT BALLOONS. DURING A FOURTH PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING TWO NON MDT BALLOONS. DURING A FIFTH PROCEDURE THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT ADMIRAL BALLOON AND FOUR NON MDT BALLOONS. DURING A SIXTH PROCEDURE, THE IN CANNULATION ZONE OF THE LEFT ARM WAS TREATED WITH 6 NON MDT BALLOONS. DURING A SEVENTH PROCEDURE, THE CENTRAL VEIN OF THE LEFT ARM WAS TREATED WITH TWO NON MDT BALLOONS. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE, 14 MONTHS POST THE SECOND PROCEDURE, 11 MONTHS POST THE THIRD PROCEDURE, 10 MONTHS POST THE FOURTH PROCEDURE, 7 MONTH POST THE FIFTH PROCEDURE, 6 MONTHS POST THE SIXTH PROCEDURE AND 3 MONTHS POST THE SEVENTH PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE PATIENT PRESENTED FOR A ROUTINE FISTULAGRA

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17779610 ↗
• InjuryJan 11, 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 WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT AV ACCESS BALLOON AND ONE NON MDT BALLOON EACH. DURING A FOURTH PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING TWO NON MDT BALLOONS. DURING A FIFTH PROCEDURE THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT ADMIRAL BALLOON AND FOUR NON MDT BALLOONS. APPROXIMATELY 11 MONTHS POST THE INDEX PROCEDURE, 8 MONTHS POST THE SECOND PROCEDURE, 5 MONTHS POST THE THIRD PROCEDURE, 4 MONTHS POST THE FOURTH PROCEDURE AND 1 MONTH POST THE FIFTH PROCEDURE, THE PATIENT SUFFERED FROM RESTENOSIS OF THE CANNULATION ZONE OF THE BRACHIO-BASILIC AVF. THE PATIENT WAS TREATED WITH MEDICATION AND A PERCUTANEOUS INTERVENTION WITH DCB, PLAIN BALLOON, HIGH PRESSURE BALLOON AND CUTTING BALLOON RESULTING IN A FINAL RESIDUAL STENOSIS OF 15%. DURING THIS PERCUTANEOUS INTERVENTION 6 NON MDT BALLOONS WERE USED TO TREAT THE IN CANNULATION ZONE OF THE L

  Patient problems: Stenosis

  MAUDE report 16136159 ↗
• InjuryDec 12, 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 IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE TO TREAT AE1, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT AV ACCESS BALLOON AND ONE NON MDT BALLOON EACH (AE2). DURING A FOURTH PROCEDURE, TWO NON MDT BALLOONS WERE USED TO TREAT THE ANASTOMOSIS OF THE LEFT ARM. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, 8 MONTHS POST THE SECOND PROCEDURE, 4 MONTHS POST THE THIRD PROCEDURE AND 3 MONTHS POST THE FOURTH PROCEDURE, THE PATIENT SUFFERED FROM RESTENOSIS OF THE CANNULATION ZONE OF THE BRACHIO-BASILIC AVF. ANGIOGRAPHY SHOWED AREAS OF RESTENOSIS IN THE CANNULATION ZONE (INDEX TREATED LESION) AND RESTENOSIS OF THE CENTRAL VEIN. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM USING ONE IN.PACT ADMIRAL BALLOON CATHETER (PLI40), FOUR NON MDT BALLOONS AND A FOGARTY EMBOLECTOMY CATHETER. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Stenosis

  MAUDE report 15958007 ↗
• InjuryNov 9, 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 WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM JUXTA ANASTOMOTIC STENOSIS OF THE BRACHIOBASILIC AVF WHICH WAS TREATED WITH MEDICATION AND A PCI. THE PCI WAS PERFORMED IN THE ANASTOMOSIS OF THE LEFT ARM USING A NON MDT BALLOON. THE PATIENT RECOVERED. THE CEC ADJUDICATED THE EVENT AS A CLINICALLY DRIVEN TLR INTERVENTION. THE CEC ADJUDICATED THE EVENT AS RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. THE SITE HAD COMMENTED THAT THE TREATMENT AREA IS NOT WITHIN THE TARGET LESION OF THE INDEX PROCEDURE. THE CEC COMMENTED THAT THEY ADJUDICATED THE EVENT AS RELATED TO THE STUDY DEVICE AND AS A TLR INTERVENTION BECAUSE "AS PER CORE LABORATORY ANALYSIS, THE SUBJECT DID HAVE REVASCULARIZATION OF THE TARGET LESION. MAYBE THE INDICATION WAS OUTSIDE OF THE LESION, BUT THE TARGET LESION WAS TOUCHED DURING THE PROCEDURE. THIS WOULD BE THE REASONING FOR THE CEC ADJUDICATION¿.

  Patient problems: Stenosis

  MAUDE report 15757945 ↗
• InjurySep 30, 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 IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT AV ACCESS BALLOON AND ONE NON MDT BALLOON EACH. APPROXIMATELY 7 MONTHS POST PROCEDURE, 4 MONTHS POST THE SECOND PROCEDURE AND 1 MONTH POST THE THIRD PROCEDURE, THE PATIENT SUFFERED FROM RESTENOTIC ANASTOMOSIS OF THE BRACHIOBASILIC AVF. THE EVENT WAS TREATED WITH MEDICATION AND A PERCUTANEOUS INTERVENTION OF THE LEFT ANASTOMOSIS USING TWO NON MDT BALLOONS. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE CEC ADJUDICATED THE EVENT AS SERIOUS ADVERSE EVENT THAT WAS A TARGET LESION REVASCULARIZATION NOT CLINICALLY DRIVEN.

  Patient problems: Stenosis

  MAUDE report 15517675 ↗
• InjurySep 28, 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 IN CANNULATION ZONE OF THE LEFT ARM. DURING ANOTHER PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM RECURRENT STENOSIS OF THE BRACHIOBASILIC VEIN FISTULA. A FISTULAGRAM SHOWED SEVERE FUSIFORM STENOSIS OF THE JUXTA ANASTOMOTIC VEIN IN THE AREA PREVIOUSLY TREATED AND DE NOVO STENOSIS IN THE CEPHALIC ARCH. THE JUXTA ANASTOMOTIC VEIN/ANASTOMOSIS AND THE CENTRAL VEIN WERE TREATED WITH BALLOONING USING TWO IN.PACT AV ACCESS BALLOONS AND TWO NON MDT BALLOONS. THE EVENT WAS ALSO TREATED WITH MEDICATION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE SITE CONFIRMED THAT THE LESION TREATED DURING THE PCI WAS NOT A TARGET LESION. THE CEC ADJUDICATED THE EVENT AS A CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION.

  Patient problems: Stenosis

  MAUDE report 15500498 ↗

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