IN.PACT™ AV IAV07004008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000232610), received between Aug 31, 2022 and Sep 20, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 17779620 ↗
• InjurySep 19, 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. APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE, 11 MONTHS POST THE SECOND PROCEDURE, 8 MONTHS POST THE THIRD PROCEDURE, 7 MONTHS POST THE FOURTH PROCEDURE, 4 MONTH POST THE FIFTH PROCEDURE AND 3 MONTHS POST THE SIXTH PROCEDURE, THE PATIENT SUFFERED FROM CENTRAL VEIN RESTENOSIS OF THE AV FISTULA. THE PATIENT PRESENTED FOR A ROUTINE FISTULAGRAM. THE IMAGING SHOWED 90% RESTENOSIS OF THE CENTRAL VEIN (NON INDEX LESION). THE EVENT WAS SUCCESSFULLY TREATED WITH A HIGH PRESSURE

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17772288 ↗
• InjuryAug 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 ARTERIAL INFLOW OF THE LEFT ARM. APPROXIMATELY 11 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM AN PSEUDOANEURYSM OF THE DISTAL PORTION OF THE LEFT FOREARM AV FISTULA. A BUMP WAS NOTED AT THE DISTAL PORTION OF THE LEFT AV FISTULA. NO PAIN, BLEEDING OR CANNULATION ISSUES OCCURRED. THE EVENT WAS TREATED WITH A TARGET LESION REVASCULARIZATION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Pseudoaneurysm

  MAUDE report 17570254 ↗
• 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, 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, 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, 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 15958012 ↗
• InjurySep 19, 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 ARTERIAL INFLOW OF THE LEFT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM LEFT ARTERIOVENOUS FISTULA STENOSIS. THE PATIENT HAD TARGET LESION RESTENOSIS EXTENDING INTO A PREVIOUSLY PLACED NON MDT STENT. THE PATIENT WAS TREATED WITH A TARGET LESION PERCUTANEOUS INTERVENTION OF THE ARTERIAL INFLOW OF THE LEFT ARM USING A BALLOON. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Stenosis

  MAUDE report 15444535 ↗
• InjuryAug 31, 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.

  Patient problems: Stenosis

  MAUDE report 15326371 ↗

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