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IN.PACT™ Admiral™ ADM07004013PRecalls & reported problems

Medtronic, Inc. · DEB ADM07004013P 07.00 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
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169383340), received between Sep 11, 2018 and Oct 24, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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

  1. 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

  • Leak/Splash2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 24, 2018Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A IN.PACT ADMIRAL WITH A 7FR SHEATH TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL COMMON ILIAC ARTERY. ARTERY DIAMETER AND LESION LENGTH WERE 7MM <(>&<)> 40MM RESPECTIVELY. IT WAS REPORTED THAT A PINHOLE LEAK OCCURRED DURING INFLATION AT 8 ATM. THE PINHOLE WAS OBSERVED AT THE BASE OF THE BALLOON. NO FRAGMENTS OF THE BALLOON REMAINED IN THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7999121 ↗
  • MalfunctionSep 11, 2018Leak/Splash; Leak/Splash

    THE PHYSICIAN WAS ATTEMPTING TO USE A IN.PACT ADMIRAL WITH A NON-MDT (7 DESTINATION TERUMO) AND A NON-MDT (0.035 GLIDEWIRE) TO TREAT A 375MM MODERATELY CALCIFIED PLAQUE LESION WITH CTO (CHRONIC TOTAL OCCLUSION 100%) IN THE RIGHT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY (6-7MM DIAMETER). LITTLE TORTUOSITY WAS REPORTED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED. NO EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED USING A NON-MDT (BOSTON SCIENTIFIC) INFLATION DEVICE. SALINE AND CONTRAST FLUID WERE USED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED BY THE TECHNICIAN THAT DURING THE FIRST BALLOON INFLATION TO 10ATM THE BALLOON WAS LEAKING WHERE THE SHAFT ATTACHES TO THE HUB. THE PHYSICIAN EXPRESSED CONCERN THE BALLOON WAS NOT HOLDING PRESSURE. THE BALLOON WAS REMOVED AS ONE PIECE. NO VISUAL DAMAGE COULD BE SEEN. THE PROCEDURE WAS COMPLETED USING ANOTHER 7X40 DRUG COATED BALLOON. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7863528 ↗

Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page