IN.PACT™ AV IAV05004004PRecalls & reported problems
Medtronic, Inc. · DCB IAV05004004P 05.00 L040 UL0400 US · Class 3
All models of IN.PACT AV (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000232771), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 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. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED ARTERIOVENOUS FISTULA STENOSIS. PATIENT CAME IN FOR DAY SURGERY DUE TO DIFFICULTY CANNULATING LEFT ARM ARTERIAL VENOUS FISTULA. PATIENT UNDERWENT FISTULOGRAM WITHOUT COMPLICATIONS. PATIENT DISCHARGED IN STABLE CONDITION SAME DAY. RECURRENT STENOSIS AT INDEX LESION. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.
Patient problems: Stenosis
MAUDE report 22733639 ↗
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, ClassifiedMedtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Other Drug-coated peripheral transluminal angioplasty catheter devices
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575760VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter2 deaths60 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575860VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter3 deaths54 reports
- IN.PACT™ AV IAV06008008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter1 recall1 report
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35751060VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter25 reports
- IN.PACT™ AV IAV08004008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter21 reports
- IN.PACT™ AV IAV08006008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter19 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575660VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter1 death19 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575840VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page