IN.PACT™ AV IAV05008008PRecalls & reported problems
Medtronic, Inc. · DCB IAV05008008P 05.00 L080 UL0800 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000232535), received between Sep 3, 2025 and Sep 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2025Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN WAS ATTEMPTING TO USE IN.PACT AV BALLON TO TREAT PATIENT'S CEPHALIC VEIN. A 6FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE WAS USED. THE DEVICE WAS PREPPED PER IFU AND SYRINGE WAS USED TO INFLATE THE BALLOON. IT WAS REPORTED DURING FIRST INFALTION A BALLOON BURST OCCURRED AND EXTENDED AT NOMINAL PRESSURE OF 8 ATMOSPHERE. RESISTANCE OCCURED DURING DELIVERY. THE BALLOON WAS REMOVED. NO PATIENT INJURY REPORTED.BUR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952354 ↗
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.
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