IN.PACT™ AV IAV08008008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000232665), received between Oct 5, 2021 and Feb 7, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 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 WERE USED TO TREAT THE LEFT ARM. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED ESRD. RE-INTERVENTION IN THE BASILIC VEIN TRANSPOSITION FISTULOGRAM DEMONSTRATES MODERATE STENOSIS IN THE PROXIMAL BASILIC OUTFLOW VEIN, AN AREA OF MODERATE IN-STENT STENOSIS; PULSATILE FLOW. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Renal Failure; Stenosis

  MAUDE report 21332277 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE CANNULATION ZONE, STENT EDGE AND IN STENT STENOSIS OF A STENT GRAFT IN THE RIGHT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE ARTERIOVENOUS GRAFT IN THE PROXIMAL NON CANNULATION ZONE AND CANNULATION ZONE SEGMENT. THE PATIENT UNDERWENT A SHUNTAGRAM. THE PRIMARY LESION INCLUDED THE PROXIMAL NON CANNULATION ZONE AND THE CANNULATION ZONE SEGMENT. THE ENROLLMENT LESION WAS TANDEM AND INCLUDED THE CANNULATION ZONE, LEADING EDGE OF STENT AND IN STENT STENOSIS IN THE STENT GRAFT. THE SHUNTAGRAM WAS COMPLETED. A PERCUTANEOUS INTERVENTION WAS PERFORMED. NO STENOSIS WAS NOTED AFTER COMPLETION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18082174 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE CANNULATION ZONE, STENT EDGE AND IN STENT STENOSIS OF A STENT GRAFT IN THE RIGHT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE ARTERIOVENOUS GRAFT IN THE PROXIMAL NON CANNULATION ZONE AND CANNULATION ZONE SEGMENT. THE PATIENT UNDERWENT A SHUNTAGRAM. THE PRIMARY LESION INCLUDED THE PROXIMAL NON CANNULATION ZONE AND THE CANNULATION ZONE SEGMENT. THE ENROLLMENT LESION WAS TANDEM AND INCLUDED THE CANNULATION ZONE, LEADING EDGE OF STENT AND IN STENT STENOSIS IN THE STENT GRAFT. THE SHUNTAGRAM WAS COMPLETED. A PERCUTANEOUS INTERVENTION WAS PERFORMED. NO STENOSIS WAS NOTED AFTER COMPLETION. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18082166 ↗
• InjuryOct 25, 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 IN CANNULATION ZONE OF THE LEFT ARM. APPROXIMATELY 13 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE ARTERIOVENOUS GRAFT. DURING AN OFFICE VISIT THE PATIENT COMPLAINED OF DIFFICULT CANNULATION AND A SHUNTAGRAM WAS SCHEDULED. THE SHUNTAGRAM WAS PERFORMED AND STENOSIS WAS NOTED. THE PRIMARY TANDEM LESION INCLUDED THE CANNULATION ZONE, LEADING EDGE OF STENT AND TRAILING EDGE OF STENT. THE ENROLLMENT LESION WAS THE CANNULATION ZONE. TWO NON MDT ANGIOPLASTY BALLOONS WERE USED ON THIS LESION WITH NO RESIDUAL STENOSIS. A TANDEM SECONDARY LESION WAS ALSO NOTED AND INCLUDED THE PROXIMAL NON CANNULATION ZONE AND THE CANNULATION ZONE SEGMENT. TWO NON MDT ANGIOPLASTY BALLOONS WERE ALSO USED ON THIS LESION WITH NO RESIDUAL STENOSIS. THE SPONSOR COMMENTED THAT THE TARGET LESION WAS INVOLVED. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18001965 ↗
• InjuryOct 25, 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 IN CANNULATION ZONE OF THE LEFT ARM. APPROXIMATELY 16 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS IN THE LESION IN THE ARTERIOVENOUS GRAFT. DURING AN OFFICE VISIT, MULTIPLE STENOTIC LESIONS WERE NOTED. A SHUNTAGRAM WAS SCHEDULED. A PRIMARY TANDEM LESION OF THE CANNULATION ZONE, DISTAL NON CANNULATION ZONE SEGMENT AND THE LEADING EDGE OF THE STENT WAS NOTED. THE ENROLLMENT LESION WAS THE CANNULATION ZONE. AN ANGIOPLASTY WAS PERFORMED AND A DRUG COATED BALLOON WAS USED. NO RESIDUAL STENOSIS WAS NOTED AT THE END OF THE PROCEDURE. THE SPONSOR COMMENTED THAT THE TARGET LESION WAS INVOLVED. THE PATIENT RECOVERED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18001816 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. APPROXIMATELY 6 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM TANDEM LESIONS OF THE CANNULATION ZONE SEGMENT, DISTAL NON CANNULATION ZONE SEGMENT AND TRAILING EDGE OF THE STENT SECONDARY TO INTIMAL HYPERPLASIA. DECREASED THRILL AND CANNULATION DIFFICULTY WAS REPORTED. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE TARGET LIMB IN CANNULATION ZONE FOR IN-STENT RESTENOSIS (SYNTHETIC RESTENOTIC GRAFT STENT). THE STENT GRAFT WAS PRESENT BEFORE THE INDEX PROCEDURE. THE INDEX LESION WAS LOCATED IN THE IN CANNULATION ZONE SEGMENT, THEREFORE THIS INTERVENTION WAS ALSO CONSIDERED A TARGET LESION REVASCULARIZATION (TLR). THE PATIENT RECOVERED. THE AE WAS ASSESSED AS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 15689954 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE IN CANNULATION ZONE OF THE RIGHT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE VENOUS ANASTOMOSIS, ARTERIAL INFLOW, PROXIMAL NON CANNULATION ZONE SEGMENT, CANNULATION ZONE SEGMENT, DISTAL NON CANNULATION ZONE SEGMENT AND LEADING EDGE OF THE STENT. THE DIALYSIS CLINIC REPORTED INCREASED CANNULATION DIFFICULTY. THE EVENT WAS TREATED WITH A TARGET LESION REVASCULARIZATION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS PROBABLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 15678584 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN. PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE IN CANNULATION ZONE OF THE RIGHT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS OF THE VENOUS ANASTOMOSIS, ARTERIAL INFLOW, PROXIMAL NON CANNULATION ZONE SEGMENT, CANNULATION ZONE SEGMENT, DISTAL NON CANNULATION ZONE SEGMENT AND LEADING EDGE OF THE STENT. THE DIALYSIS CLINIC REPORTED INCREASED CANNULATION DIFFICULTY. THE EVENT WAS TREATED WITH A TARGET LESION REVASCULARIZATION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS PROBABLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 15678563 ↗
• MalfunctionMay 24, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN USED AN INPACT AV DRUG-COATED BALLOON WITH A 7FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 60MM PLAQUE LESION IN THE PATIENT'S PROXIMAL SUPERFICIAL FEMORAL ARTERY OF DIAMETER 8MM. PHYSICIAN NEEDED AN 8MM DRUG COATED BALLOON AND CHOOSE TO USE THE IAV AS WE DO NOT HAVE 8MM IPA, HE WAS ADVISED BY STAFF IT WAS AN IAV AND CHOSE TO USE IT. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 50% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. BALLOON INFLATION DIFFICULTIES ARE REPORTED. THE INPACT AV WAS ADVANCED OVER THE WIRE TO THE LESION TO BE TREATED. THE INFLATION DEVICE WAS ATTACHED TO THE BALLOON AND INFLATION INITIATED. THE BALLOON WOULD NOT INFLATE AND IT WAS NOTED THE HUB OF THE BALLOON WAS LEAKING. THE BALLOON WAS REMOVED. AN 8X80 EVERCROSS WAS USED TO COMPLETE THE PROCEDUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492426 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS PTA BALLOON CATHETERS WERE USED TO TREAT AN IN CANNULATION ZONE LESION LOCATED IN THE RIGHT ARM. APPROXIMATELY 3 MONTHS POST PROCEDURE PATIENT SUFFERED FROM 75% RESTENOSIS IN THE CANNULATION ZONE SEGMENT. THE EVENT WAS TREATED WITH REVASCULARIZATION IN THE TANDEM PROXIMAL NON CANNULATION ZONE SEGMENT AND ARTERIAL INFLOW IN THE RIGHT ARM. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 12574963 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS PTA BALLOON CATHETERS WERE USED TO TREAT AN IN CANNULATION ZONE LESION LOCATED IN THE RIGHT ARM. APPROXIMATELY 3 MONTHS POST PROCEDURE PATIENT SUFFERED FROM 75% RESTENOSIS IN THE CANNULATION ZONE SEGMENT. THE EVENT WAS TREATED WITH REVASCULARIZATION IN THE TANDEM PROXIMAL NON CANNULATION ZONE SEGMENT AND ARTERIAL INFLOW IN THE RIGHT ARM. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 12574960 ↗

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