IN.PACT™ Admiral™ ADM07008013PRecalls & reported problems
Medtronic, Inc. · DEB ADM07008013P 07.00 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
- 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 00643169383364), received between May 22, 2023 and May 22, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
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
- Detachment of Device or Device Component1
- Difficult to Remove1
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.
MalfunctionMay 22, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE AN IMPACT ADMIRAL DRUG COATED BALLOON WITH A 7FR NON-MEDTRONIC (MERIT PRELUDE PRO) SHEATH AND A NON-MEDTRONIC (TERUMO GLIDE ADVANTAGE) GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS MID COMMON ILIAC ARTERY. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION IS REPORTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. CASE WAS OVER AND PROCEDURE WAS COMPLETED FINE, BALLOON CATHETER BROKE AND CAUGHT ON THE SHEATH WHILE REMOVING. REMOVED SHEATH WITH BALLOON INSIDE, EVERYTHING CAME OUT FINE AND THE DEVICE SAFELY REMOVED FROM THE PATIENT. NO VESSEL DAMAGE AND NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973838 ↗
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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