IN.PACT™ AV IAV07004004PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000232870), received between Mar 26, 2024 and Jan 8, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 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. ANOTHER TWO IN.PACT AV ACCESS DEVICES WERE USED LATE R. APPROXIMATELY 15 MONTHS POST PROCEDURE PATIENT SUFFERED RECURRENT STENOSIS OF ANASTOMOSIS AND INFLOW PORTION OF LEFT ARTERIOVENOUS FISTULA. RECURRENT MODERATE STENOSIS WITHIN INFLOW PORTION OF LEFT CIMINO FISTULA. BALLOON ANGIOPLASTY OF THE ARTERIOVENOUS ANASTO MOSIS AND INFLOW PORTION OF THE FISTULA. THIS WAS FOR THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21102732 ↗
• InjuryJan 8, 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. ANOTHER TWO IN.PACT AV ACCESS DEVICES WERE USED LATE R. APPROXIMATELY 15 MONTHS POST PROCEDURE PATIENT SUFFERED RECURRENT STENOSIS OF ANASTOMOSIS AND INFLOW PORTION OF LEFT ARTERIOVENOUS FISTULA. RECURRENT MODERATE STENOSIS WITHIN INFLOW PORTION OF LEFT CIMINO FISTULA. BALLOON ANGIOPLASTY OF THE ARTERIOVENOUS ANASTOMOSIS AND INFLOW PORTION OF THE FISTULA. THIS WAS FOR THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21102623 ↗
• InjuryJul 18, 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 LEFT ARM SWING POINT. ANOTHER IN.PACT AV ACCESS WAS LATER USED. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS SWING SEGMENT BASILIC. FISTULOGRAM PERFORMED DEMONSTRATED MODERATE STENOSIS SWING SEGMENT BASILIC VEIN (ORIGINAL TARGET LESION) IN MID HUMERAL REGION. TREATED SUCCESSFULLY BOTH ANGIOPLASTY AND DRUG COATED BALLOON. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19772594 ↗
• InjuryApr 11, 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. 2 MONTHS LATER AN IN.PACT AV ACCESS BALLOON WAS USED DURING A REVASCULARIZATION PROCEDURE TO TREAT THE LEFT ARM. APPROXIMATELY 6 MONTHS POST INITIAL PROCEDURE AND 4 MONTHS REVASCULARIZATION PROCEDURE THE PATIENT SUFFERED RECURRENT STENOSIS OF LEFT AV FISTULA, TARGET LESION. PATIENT UNDERWENT REVISION OF LEFT CEPHALIC AND AV ANASTOMOSIS WITH RECURRING STENOSIS. MULTI-BALLOON ANGIOPLASTY WAS PERFORMED. THIS PROCEDURE WAS FOR THE TARGET LESION. MEDTRONIC DCB WAS USED DURING THIS PROCEDURE. PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE AND  PACLITAXEL. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE INDEX PROCEDURE OR PACLITAXEL. EVENT IS RESOLVED.

  Patient problems: Stenosis

  MAUDE report 19086001 ↗
• InjuryMar 26, 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. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOTIC AV FISTULA. STENOSIS IN CEPHALIC ARCH OF RIGHT BRACHIOCEPHALIC AV FISTULA. SUCCESSFUL DRUG COATED BALLOON ANGIOPLASTY PERFORMED. ONE DRUG COATED SABER BALLOON WAS USED FOLLOWED BY A PACLITAXEL COATED MEDTRONIC IN.PACT ADMIRAL BALLOON. A SABER BALLOON WAS THEN USED AGAIN. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18977584 ↗

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