IN.PACT™ Admiral™ ADM06012013P (UDI 00643169383289)Recalls & reported problems
Medtronic, Inc. · DEB ADM06012013P 06.00 L120 UL1300 US · Class 3
All models of IN.PACT Admiral (39)
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 00643169383289), received between Apr 6, 2017 and Apr 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (P140010); 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
Device problems
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2017Inflation Problem; Inflation Problem
PHYSICIAN WAS ATTEMPTING TO TREAT A MODERATELY CALCIFIED LESION IN THE SFA TO POPLITEAL USING IN PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER. IT WAS ALLEGED THAT A BALLOON TWIST WAS NOTED DURING INFLATION. PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WAS NO INJURY TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6463297 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140010. One submission often covers many models, so check the product and lot details in each record.
- Z-1042-2022 · Mar 23, 2022 · Open, ClassifiedMedtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM040120
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- 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
- 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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