IN.PACT™ Admiral™ ADM04004013PRecalls & reported problems
Medtronic, Inc. · DEB ADM04004013P 04.00 L040 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169383500), received between May 16, 2018 and Nov 10, 2025 — classified as 1 injury, 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-1042-2022 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
- Restenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RESTENOSIS OF A LESION IN THE PATIENTS ARTERIOVENOUS FISTULA (AVF) OCCURRED WITHIN SEVEN MONTHS AFTER TREATMENT WITH AN INPACT ADMIRAL DRUG COATED BALLOON. A NEW INPACT AV DRUG COATED BALLOON WAS USED FOR RETREATMENT. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: Restenosis
MAUDE report 23508460 ↗MalfunctionMay 16, 2018Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL FOR TREATMENT OF A LESION LOCATED IN THE PATIENTS RIGHT SUPERFICIAL FEMORAL ARTERY, OST IAL/PROXIMAL TO THE PROFUNDA. THE LESION WAS CALCIFIED BUT NOT TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE, SHEATH AND GUIDEWIRE WAS USED. THE LESION WAS PREDILATED USING A NON-MEDTRONIC BALLOON. INFLATION FLUID USED WAS 50/50 CONTRAST TO HEP SALINE. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING THE FIRST INFLATION AT 12 ATMS. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT FRAGMENTATION/FURTHER ISSUE. ANOTHER IN.PACT ADMIRAL BALLOON ALONG WITH THE PREVIOUSLY USED NON-MEDTRONIC BALLOON WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7517595 ↗
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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