IN.PACT™ AV IAV09008008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000232696), received between Nov 16, 2021 and Jun 27, 2024 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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.

• InjuryJun 27, 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 BALLOON WAS USED TO TREAT THE RIGHT IN CANNULATION ZONE. APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE SHUNTAGRAM SHOWED A TANDEM PRIMARY LESION AT THE SWING SEGMENT AND DISTAL NON-CANNULATION ZONE ( INDEX LESION WAS AT THE CANNULATION ZONE) AND THE LESION WAS TREATED SUCCESSFULLY WITH PERCUTANEOUS INTERVENTION. NO RESIDUAL STENOSIS AT THE END OF THE PROCEDURE. THE EVENT IS RESOLVED.

  Patient problems: Stenosis

  MAUDE report 19624129 ↗
• InjuryApr 2, 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. APPROXIMATELY 16 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS OF ARTERIOVENOUS GRAFT AT AXILLARY VEIN AND SECONDARY TANDEM LESION AT ARTERIAL INFLOW AND PROXIMAL NON-CANNULATION ZONE. SHUNTAGRAM SCHEDULED AFTER ULTRASOUND IDENTIFIED STENOSIS OF THE ARTERIOVENOUS GRAFT DURING EXAM; SHUNTAGRAM NOTED PRIMARY LESION WITH STENOSIS OF THE AXILLARY VEIN AND SECONDARY TANDEM LESION WITH STENOSIS NOTED AT ARTERIAL INFLOW AND PROXIMAL NON-CANNULATION ZONE. THE ENROLMENT LESION WAS NOTED TO BE THE VENOUS ANASTOMOSIS AND WAS NOT INVOLVED IN THIS PROCEDURE. TREATMENT FOR THE LESIONS NOTED, INCLUDED ANGIOPLASTY AND DRUG COATED BALLOON. NO RESIDUAL STENOSIS NOTED AFTER PROCEDURE. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19019600 ↗
• InjuryApr 2, 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. APPROXIMATELY 20 MONTHS POST PROCEDURE PATIENT SUFFER ED STENOSIS OF ARTERIOVENOUS GRAFT AT CANNULATION ZONE. PATIENT NOTED TO HAVE STENOSIS OF ARTERIOVENOUS GRAFT AND SHUNTOGRAM COMPLETED. SHUNTOGRAM HAD PRIMARY LESION WITH STENOSIS OF THE CANNULATION ZONE. ENROLMENT LESION NOTED TO BE THE VENOUS ANASTOMOSIS. THE PRIMARY LESION DURING THIS PROCEDURE WAS TREATED WITH AN ANGIOPLASTY BALLOON AND NO RESIDUAL STENOSIS NOTED. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19019560 ↗
• InjuryNov 7, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE AN INPACT AV ACCESS DRUG COATED BALLOON WITH A 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A FIBROUS LESION IN THE PATIENTS MID BRACHIAL CEPHALIC ARTERY. NO VESSEL TORTUOSITY AND NO VESSEL CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THE BALLOON BROKE APART AND THE TIP SEPARATED DURING BALLOON INFLATION AT RBP. PIECES OF THE BALLOON HAD TO BE SNARED FROM THE ARTERY AND THE NON-MEDTRONIC SHEATH HAD TO BE REMOVED TO PULL THE BROKEN BALLOON FROM THE PATIENT, AND ACCESS WAS LOST. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082947 ↗
• InjuryNov 6, 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 ANASTOMOSIS OF THE LEFT ARM. APPROXIMATELY 16 MONTHS POST THE INDEX PROCEDURE THE PATIENT UNDERWENT A REVASCULARIZATION PROCEDURE DURING WHICH AN IN.PACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE AXILLARY VEIN AND ARTERIAL INFLOW AND PROXIMAL NON CANNULATION ZONE OF THE LEFT ARM. APPROXIMATELY 26 MONTHS POST THE INDEX PROCEDURE AND 9 MONTHS POST THE REVASCULARIZATION PROCEDURE THE PATIENT SUFFERED FROM THROMBOSIS OF THE ARTERIOVENOUS GRAFT AT THE TRAILING EDGE OF THE STENT. THE PATIENT REPORTED NO THRILL OR BRUIT IN THE ARTERIOVENOUS GRAFT. A SHUNTAGRAM SHOWED THROMBOSIS AT THE ANASTOMOSIS AT THE TRAILING EDGE OF A NON MDT STENT IMPLANTED PRIOR TO STUDY ENROLLMENT. THE ENROLLMENT LESION INCLUDED A SINGLE LESION OF THE VENOUS ANASTOMOSIS AND THE TRAILING EDGE OF THE STENT. TREATMENT WAS PERFORMED DURING THE SHUNTAGRAM. AN ANGIOPLASTY AND THROMBECTOMY WAS PERFORMED WHICH WAS SUCCESSFUL. THE PATIENT RECOVERED. THE SPONSOR COMMENTED THAT THIS WAS A TARGET LESION REVASCULARIZATION.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 18071734 ↗
• InjuryMar 31, 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 RIGHT ARM. APPROXIMATELY 11 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM RESTENOSIS OF THE SWING SEGMENT OF THE ARTERIOVENOUS FISTULA. DURING DIALYSIS AT THE END OF THE RUN, THE MACHINE CLOTTED OFF. UPON PHYSICAL EXAMINATION, NO THRILL OR BRUIT WERE PRESENT SO THE PATIENT WAS SCHEDULED FOR AN AVF DECLOT. IN THE OPERATING ROOM, THE PATIENT WAS NOTED TO HAVE TANDEM PRIMARY LESION AT THE ARTERIAL INFLOW AND ARTERIAL ANASTOMOSIS SECONDARY LESION AT THE SWING SEGMENT. ALL LESIONS WERE RESTENOTIC AND NO THROMBUS WAS PRESENT. THE EVENT WAS SUCCESSFULLY TREATED WITH A PERCUTANEOUS INTERVENTION USING AN ANGIOPLASTY. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS PROBABLY RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE CEC ADJUDICATED THE EVENT AS RELATED TO THE DEVICE. THE CEC COMMENTED THAT THERE WAS 85% STENOSIS OF THE TARGET LESION.

  Patient problems: Stenosis

  MAUDE report 16653769 ↗
• InjuryDec 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 VENOUS OUTFLOW OF THE LEFT ARM. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE PATIENT PRESENTED FOR A ROUTINE FISTULOGRAM WHICH SHOWED AN AREA OF 50% RESTENOSIS IN THE VENOUS OUTFLOW, THE INDEX TARGET LESION. THE EVENT WAS TREATED WITH A DCB, POBA AND HIGH PRESSURE BALLOON USING NON MDT DEVICES. RESIDUAL STENOSIS WAS 0%. THE PATIENT ALSO RECEIVED MEDICATION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Stenosis

  MAUDE report 16002457 ↗
• InjuryNov 22, 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 RIGHT ARM. APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM AN ACUTE PULMONARY EMBOLISM. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH. A CT SCAN WAS PERFORMED AND SHOWED FINDINGS AND A HISTORY OF A PULMONARY EMBOLUS IN THE RIGHT UPPER AND LOWER LOBES AND CHRONIC PULMONARY HYPERTENSION. THE PATIENT WAS TREATED WITH A COURSE OF ANTIBIOTICS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) DUE TO BRADYCARDIA, HYPOTENSION AND HYPERKALEMIA. THE PATIENT HAD EMERGENT DIALYSIS AND BECAME SYMPTOMATICALLY STABLE AND IMPROVED AND WAS MOVED OUT OF THE ICU. THE PATIENT WAS LATER DISCHARGED. THE PATIENT RECOVERED. THE PATIENT HAD UNDERWENT A THROMBECTOMY OF THE RIGHT ARM ONE DAY PRIOR TO THE START OF THIS AE. THE AE WAS ASSESSED AS PROBABLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Bradycardia; Dyspnea; Electrolyte Imbalance; Low Blood Pressure/ Hypotension; Pulmonary Embolism; Pulmonary Hypertension

  MAUDE report 15841954 ↗
• InjuryNov 21, 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 RIGHT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM STENOSIS IN THE IN CANNULATION ZONE. AN EXAMINATION OF THE FISTULA SHOWED MINIMAL THRILL AND BRUIT IN THE CANNULATION ZONE. THE PATIENT UNDERWENT A SHUNTOGRAM. IN THE OPERATING ROOM, IT WAS NOTED THAT THE PATIENT HAD TANDEM PRIMARY LESIONS AT THE ARTERIAL INFLOW, ARTERIAL ANASTOMOSIS, SWING SEGMENT AND CANNULATION ZONE SEGMENT. THE EVENT WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS INTERVENTION WHICH RESULTED IN NO RESIDUAL STENOSIS. THE PATIENT RECOVERED. THE SPONSOR CONFIRMED THE EVENT WAS A TARGET LESION REVASCULARIZATION (TLR). THE AE WAS ASSESSED AS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Stenosis

  MAUDE report 15832705 ↗
• InjuryNov 21, 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 RIGHT ARM. APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM THROMBOSIS OF THE FISTULA. THE PATIENT EXPERIENCED CLOTTING AND DIFFICULTY CANNULATING THE FISTULA. AN ULTRASOUND WAS PERFORMED AND CONFIRMED EVIDENCE OF THROMBOSIS IN THE ARTERIAL VENOUS ANASTOMOSIS TO THE VENOUS OUTFLOW AT THE MEDIAN CUBICAL VEIN. THE THROMBOSIS OF THE FISTULA WAS CONFIRMED AS INVOLVING THE TARGET LESION. THE EVENT WAS TREATED WITH A FISTULA DE-CLOT/THROMBECTOMY IN THE RIGHT ARM. THE PATIENT RECOVERED. THE AE ASSESSED THE EVENT AS POSSIBLY RELATED TO AN UNDERLING CONDITION OR DISEASE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15832641 ↗
• MalfunctionNov 16, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE INPACT AV ACCESS DCB DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID LEFT SUBCLAVIAN ARTERY. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP./TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION A LONGITUDINAL BURST OCCURRED AT 10 ATM. ALL FRAGMENTS OF THE BALLOON WAS RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NOTHING WAS USED AFTER THIS TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820523 ↗

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