IN.PACT™ Admiral™ ADM04012013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169383531), received between Apr 29, 2019 and Feb 21, 2024 — classified as 1 death, 5 injuries, 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.

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A IN.PACT ADMIRAL WAS USED TO TREAT THE POPLITEAL 1 SEGMENT. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED CHRONIC RLE CRITICAL LIMB ISCHEMIA. NON-HEALING DORSAL RIGHT FOOT WOUND AND ISCHEMIC REST PAIN. THE EVENT WAS TREATED WITH RIGHT ABOVE KNEE POPLITEAL TO DISTAL PERONEAL VEIN GRAFT BYPASS. PATIENT RECOVERING.

  Patient problems: Ischemia

  MAUDE report 18747452 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A IN.PACT ADMIRAL WAS USED TO TREAT THE POPLITEAL 1 SEGMENT. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED REOCCLUSION OF THE RIGHT TIBIAL VESSELS. PATIENT PRESENTED WITH NONHEALING WOUND OF PREVIOUS TENDON RESECTION POST PREVIOUS INTERVENTION TO POP, TPT, AT, DP. INDEX TARGET LIMB INVOLVEMENT. THE EVENT WAS TREATED WITH RIGHT LOWER ANGIOGRAPHY WITH DISTAL RUNOFF. PATIENT RECOVERING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18747367 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IMPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE POPLITEAL 3 SEGMENT AND THE TIBIAL PERONEAL OF THE RIGHT LIMB (R1). APPROXIMATELY 15 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM WORSENING PERIPHERAL ARTERY DISEASE OF THE RIGHT LEG. THE PATIENT PRESENTED WITH RECURRENT SYMPTOMS OF INTERMITTENT CLAUDICATION BUT NO WOUNDS OR ULCERS. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION WITH RE-INTERVENTION OF THE TARGET LIMB DURING WHICH THE RIGHT PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERY, POPLITEAL (1,2 AND 3 SEGMENTS), TIBIO-PERONEAL TRUNK AND PERONEAL ARTERIES WERE TREATED. THIS INTERVENTION WAS CONFIRMED TO BE A TARGET LESION REVASCULARIZATION. THE PATIENT RECOVERED.

  Patient problems: Arteriosclerosis/ Atherosclerosis; Insufficient Information; Pain; Restenosis

  MAUDE report 16119990 ↗
• MalfunctionMar 24, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE INPACT ADMIRAL DCB ALONG WITH NON-MEDTRONIC 6FR X 45CM SHEATH AND 300M GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 4MM AND 80MM RESPECTIVELY. THERE WAS NO EMBOLIC PROTECTION USE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A 50/50 HEARINIZED SALINE AND CONTRAST WAS USED OR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPER PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST OCCURRED AT 14ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THERE WAS NO INTERVENTION NEED TO REMOVE THE BURST BALLOON. THERE WAS NO VESSEL DAMAGE DUE TO EVENT. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THE DEFECTIVE BALLOON WAS REMOVED, AND A NEW BALLOON WAS INSERTED AND INFLATED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892659 ↗
• DeathSep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE RIGHT MID AND DISTAL SFA. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE THE PATIENT DIED OF AN UNKNOWN CAUSE. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Death

  MAUDE report 8981305 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE RIGHT DISTAL SFA AND POPLITEAL AND ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT RIGHT DISTAL SFA. APPROX 7 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED STENOSIS OF THE SFA. 75% CONSTRICTION OF THE RIGHT SFA WAS OBSERVED. THE PATIENT WAS TREATED WITH PTA OF THE TARGET LESION. THE PATIENT RECOVERED. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 8564679 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE DISTAL SFA AND POPLITEAL AND ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT DISTAL SFA. APPROX 7 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED STENOSIS OF THE RIGHT POPLITEAL ARTERY AND SFA. 75% CONSTRICTION OF THE RIGHT SFA WAS OBSERVED. THE PATIENT WAS TREATED WITH PTA OF THE TARGET LESION. THE PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 8560385 ↗