IN.PACT™ AV IAV06008008PRecalls & reported problems
Medtronic, Inc. · DCB IAV06008008P 06.00 L080 UL0800 US · Class 3
All models of IN.PACT AV (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000232580), received between Sep 8, 2025 and Sep 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 23, 2022Class IIOpen, Classified
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Z-1043-2022 · Root cause: Packaging process control · Recall details · FDA record ↗
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 8, 2025Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN WAS ATTEMPTING TO USE IN.PACT AV BALLOON TO TREAT PLAQUE LESION IN PATIENT LEFT BASILIC VEIN. THE PRODUCT WAS PREPARED ACCORDING TO THE IFU. IT WAS REPORTED THAT A BALLOON BURST OCCURED DURING BALLOON INFALTION AT NOMINAL PRESSURE. THE EVENT OCCURRED AFTER THE DEVICE WAS EXPANDED BY APPROXIMATELY 1 MINUTE AND 30 SECONDS, SO IT WAS DETERMINED THAT THE DRUG HAD MIGRATED TO THE BLOOD VESSEL WALL. THE PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL USE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991472 ↗
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
- 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
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575960VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter14 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 · each recall links to the FDA recall notice
- 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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