IN.PACT™ Admiral™ ADM04012008PRecalls & reported problems
Medtronic, Inc. · DEB ADM04012008P 04.00 L120 UL0800 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169383487), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING INDEX PROCEDURE, TWO IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETERS WERE USED TO TREAT THE LEFT DISTAL SFA. APPROXIMATELY 5 MONTHS POST PROCEDURE, PATIENT SUFFERED CRITICAL LIMB ISCHEMIA WHICH WAS TREATED WITH REVASCULARIZATION OF THE TARGET LESION USING PTA BALLOON AND STENT. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE OR PACLITAXEL.
Patient problems: Injury
MAUDE report 8955507 ↗
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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- 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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