IN.PACT™ Admiral™ ADM04008013PRecalls & reported problems
Medtronic, Inc. · DEB ADM04008013P 04.00 L080 UL1300 US · Class 3
All models of IN.PACT Admiral (39)
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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169383524), received between May 15, 2019 and Aug 15, 2019 — classified as 2 injuries.
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.
Recalls naming this device
- Mar 23, 2022Class IIOpen, Classified
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Z-1042-2022 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Occlusion2
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE TWO INPACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE RIGHT MID SFA (R1 AND R2) . APPROX 11 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED ARTERIO SCLEROSIS OBLITERANS. OCCLUSION WAS OBSERVED IN AN ARTERY IN THE TARGET LIMB. THE PATIENT WAS TREATED WITH PTA OF THE TARGET LESION. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE, PROCEDURE OR PACLITAXEL. SAFETY ASSESSED THE EVENT AS PROBABLY RELATED TO THE INDEX DEVICE AND PROCEDURE AND POSSIBLY RELATED TO PACLITAXEL.
Patient problems: Occlusion
MAUDE report 8896154 ↗InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCBS WERE USED TO TREAT THE RIGHT MID SFA (R1 AND R2). APPROXIMATELY 4.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED ATHERIOSCLEROSIS OBLITERANS OF TARGET LESION, TARGET LIMB ARTERY WAS OCCLUDED. THE PATIENT WAS TREATED WITH PTA AND DCB OF THE TARGET LESION. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.
Patient problems: Injury; Occlusion
MAUDE report 8611779 ↗
Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices
- LUTONIX® Drug Coated Balloon LX351305150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter117 reports
- LUTONIX® Drug Coated Balloon LX351306150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter75 reports
- Ranger™ H74939419502010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Ranger™ H74939419602010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Lutonix® Drug Coated Balloon LX351305100Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter66 reports
- IN.PACT™ Admiral™ ADM06004013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall12 reports
- IN.PACT™ Admiral™ ADM06015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall11 reports
- IN.PACT™ Admiral™ ADM04015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall8 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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