IN.PACT™ Admiral™ ADM06012013P (UDI 00643169859975)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169859975), received between Jan 9, 2018 and Apr 24, 2024 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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

Recent adverse event reports

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

• InjuryApr 24, 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 SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL. IMMEDIATELY POST PROCEDURE PATIENT SUFFERED DISSECTION TYPE C. DURING INDEX PROCEDURE BALLOONING LESION OF RIGHT SFA WITH IN.PACT ADMIRAL DCB IMPROVED TARGETED STENOSIS, BUT THERE APPEARED TO BE A TYPE C DISSECTION. TARGET LESION INVOLVED. MD THEN BROUGHT IN A MEDTRONIC 7X120 EVERFLEX STENT FOR BAIL-OUT STENTING AS ASSESSED BY PROCEDURAL MD. STENT POST-DILATED AND RESOLVED DISSECTION. PATIENT RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 19171021 ↗
• MalfunctionJun 30, 2021Deflation Problem; Compatibility Problem; Deflation Problem; Compatibility Problem

  PHYSICIAN ATTEMPTED TO USE AN INPACT ADMIRAL DRUG COATED BALLOON WITH A NON-MEDTRONIC 6FR SHEATH DURING A PROCEDURE TO TREAT A LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THE INAPCT ADMIRAL WAS INCOMPATIBLE WITH THE 6FR SHEATH. THE PHYSICAL HAD TO PULL THE ENTIRE SHEATH WITH THE BALLOON INSIDE OUT. A SECOND SHEATH WAS THEN PLACED, AND THE PROCEDURE COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092434 ↗
• MalfunctionMay 25, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN INPACT ADMIRAL DURING TREATMENT OF A CTO (CHRONIC TOTAL OCCLUSION - 100%) IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT TORTUOUS. ARTERY DIAMETER WAS 6 MM AND LESION LENGTH WAS APPROXIMATELY 100-120 MM. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED. NEGATIVE PREP WAS PERFORMED. LESION WAS PRE-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS FELT, NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING FIRST BALLOON INFLATION AT 14 ATM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085049 ↗
• DeathMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO INPACT ADMIRAL PTA BALLOON CATHETERS WERE USED TO TREAT THE RIGHT SFA. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED VENTRICULAR FIBRILLATION AND DIED SUDDEN CARDIAC DEATH. IT WAS REPORTED THAT THE DEATH WAS DUE TO VENTRICULAR FIBRILLATION.

  Patient problems: Death

  MAUDE report 8448276 ↗
• MalfunctionDec 17, 2018Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  THE PHYSICIAN INTENDED TO USE THE INPACT ADMIRAL WITH A NON-MEDTRONIC 6F SHEATH AND A NON-MEDTRONIC 018 GUIDEWIRE, TO TREAT A SOFT TISSUE LESION WITH 50% STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. ARTERY DIAMETER 6MM, LESION LENGTH 110MM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE OR EXCESSIVE FORCE WAS USED. ONE SUCCESSFUL INFLATION WAS PERFORMED TO AN INFLATION PRESSURE OF 8-14ATM¿S. BALLOON INFLATION DIFFICULTIES WERE ENCOUNTERED AND THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. DEFLATION TIME WAS NOT PROVIDED. BALLOON WOULD NOT HOLD STEADY PRESSURE, BUT DILATION WAS SUCCESSFUL WHILE USING CONTINUED INFLATION. REMOVAL DIFFICULTIES WERE ALSO ENCOUNTERED AFTER BALLOON INFLATION. WHEN RETRIEVING THE DEFLATED BALLOON THROUGH THE SHEATH IT WOULD NOT COMPLETELY ENTER THE DISTAL END OF THE SHEATH. THE BALLOON AND SHEATH HAD TO BE REMOVED AND A NEW SHEATH WAS PLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169659 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF MODERATELY CALCIFIED FIBROUS LESIONS WITH 80% STENOSIS IN THE DISTAL MID LEFT SUPERFICIAL FEMORAL ARTERY (ARTERY DIAMETER 6MM), PHYSICIAN FIRST PREPPED TWO LESIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE AND THEN POST DILATED WITH TWO IN.PACT ADMIRAL BALLOONS. FOLLOWING POST-DILATION, A DISSECTION WAS NOTED IN THE DISTAL SFA AND POPLITEAL ARTERY THAT WAS DETERMINED TO REQUIRE STENTING. THE PHYSICIAN THEN USED AN EVERFLEX ENTRUST WITH A NON-MEDTRONIC 7FR. 55CM SHEATH AND A SPIDER FX 7MM EMBOLIC PROTECTION DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING DEPLOYMENT. THE PHYSICIAN DECIDED TO POST DILATE THE STENT OVER A WHOLEY WIRE THAT WAS PLACED INSIDE THE STENTED SEGMENT. HE POST-DILATED THE STENT WITH A NON-MEDTRONIC 6X100 PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) BALLOON. THE PATIENT IS REPORTED TO BE DOING FINE AND THE FINAL ANGIOGRAM SHOWED A PATENT VESSEL WITH BETTER RUNOFF TO THE DISTAL VESSELS.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 7994380 ↗
• MalfunctionJan 9, 2018Leak/Splash; Leak/Splash

  PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER FOR THE TREATMENT OF A MODERATELY CALCIFIED PLAQUE LESION IN THE SUPERFICIAL FEMORAL ARTERY. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS USED. INFLATION DEVICE WAS USED. IT WAS REPORTED THAT THERE WAS A HOLE IN THE DELIVERY CATHETER SHAFT THAT WAS REALIZED UPON INITIAL INFLATION AT A PRESSURE OF 8 ATM. DEVICE WAS REPLACE WITH ANOTHER DCB AND ANGIOPLASTY WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7177617 ↗