IN.PACT™ Admiral™ ADM06008013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169383272), received between Aug 15, 2018 and Jun 18, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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

Recent adverse event reports

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

• MalfunctionJun 18, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY DISEASE PROCEDURE TO TREAT A CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY, THE INPACT ADMIRAL DRUG COATED BALLOON 018 BURST DURING THE PROCEDURE. THE COMMON FEMORAL ARTERY WAS DESCRIBED AS HIGHLY CALCIFIED, AND VESSEL PREPARATION WAS PERFORMED USING A 7MM NON-MEDTRONIC DEVICE. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST FLUID FOR INFLATION. AFTER THE FIRST DRUG COATED BALLOON BURST ON INITIAL INFLATION, A SECOND INPACT ADMIRAL DRUG COATED BALLOON WAS USED, WHICH ALSO BURST. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AFTER THE SECOND BALLOON BURST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22267837 ↗
• MalfunctionJun 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING THE IN.PACT ADMIRAL DEVICE, THE BALLOON BURST ON THE FIRST INFLATION AT, BELOW, OR AT AN UNKNOWN RATED BURST PRESSURE, LEADING TO THE PROCEDURE BEING ABORTED. THE VESSEL HAD BEEN PRE-DILATED WITH A 7MM NON-MEDTRONIC DEVICE, AND A 6X45 NON-MEDTRONIC SHEATH AND 014X300 NON-MEDTRONIC GUIDEWIRE WERE USED. INFLATION WAS PERFORMED WITH A NON-MEDTRONIC DEVICE USING 50/50 CONTRAST. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201337 ↗
• MalfunctionFeb 28, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN INPACT ADMIRAL DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED BALLOON BURST OCCURRED DURING BALLOON INFLATION AT A PRESSURE OF 2ATM. NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9768659 ↗
• InjuryAug 20, 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 SFA AND ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE RIGHT DISTAL SFA. APPROX 1 YEAR POST INDEX PROCEDURE THE PATIENT SUFFERED RIGHT SFA OCCLUSION. 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: Occlusion

  MAUDE report 8909306 ↗
• MalfunctionMar 25, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN INPACT ADMIRAL BALLOON TO TREAT A MODERATELY CALCIFIED NON TORTUOUS PLAQUE LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY(SFA). THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUE IDENTIFIED. IT WAS REPORTED THAT UPON INFLATION, THE BALLOON DID NOT HOLD PRESSURE. THUS, IT WAS REPORTED THAT THE LESION WAS NOT TREATED FOR THE REQUIRED 3 MINUTES. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448174 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCB WERE USED TO TREAT THE LEFT DISTAL SFA AND POPLITEAL. APPROXIMATELY 8.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED LEFT SFA OCCLUSION AND WAS TREATED WITH A PTA AND STENTING OF TARGET VESSEL-NON TARGET LESION. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Occlusion

  MAUDE report 8415739 ↗
• MalfunctionAug 15, 2018Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL DEVICE WITH A NON-MEDTRONIC 0.014 WIRE FOR TREATMENT OF A CALCIFIED LESION IN THE PATIENTS POPLITEAL ARTERY. MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 70% STENOSIS. ORIBTAL ATHERECTOMY WAS CARRIED OUT PRIOR TO TREATMENT WITH THE IN.PACT ADMIRAL DEVICE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED A BALLOON RUPTURE OCCURRED AT AN UNKNOWN INFLATION PRESSURE. NO BALLOON FRAGMENTS WERE OBSERVED WHEN RUPTURED. THE RUPTURE DID NOT CAUSE ANY INJURY TO THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER IN.PACT ADMIRAL TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783978 ↗