IN.PACT™ Admiral™ ADM04015013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169576315), received between Jan 12, 2018 and Aug 22, 2019 — classified as 4 injuries, 4 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DCBS WERE USED TO TREAT THE LEFT MID SFA. APPROXIMATELY 1 YEAR POST INDEX PROCEDURE THE PATIENT UNDERWENT TARGET LESION REVASCULARISATION.

  Patient problems: Injury

  MAUDE report 8920705 ↗
• MalfunctionJun 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN INPACT ADMIRAL DCB BALLOON TO TREAT A SLIGHTLY CALCIFIED, SLIGHTLY TORTUOUS L050% STENOTIC LESION IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 4MM & 200MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A SPIDERFX WERE USED FOR THE PROCEDURE. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE AND 50/50 CONTRAST/SALINE SOLUTION WAS USED AS INFLATION FLUID. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT - NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. IT WAS REPORTED THAT THERE WAS A PINHOLE LEAK NOTED IN THE BALLOON WHEN INFLATING IT SLOWLY UP TO 8ATMS. A NEW BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703173 ↗
• 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 THE RIGHT DISTAL SFA. APPROXIMATELY 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 8564600 ↗
• 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 8560377 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN INTENDED TO USE THE INPACT ADMIRAL TO TREAT A CTO (CHRONIC TOTAL OCCLUSION) IN THE RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERY, TO TREAT IN-STENT RESTENOSIS. A SECONDARY INTERVENTION WAS CARRIED OUT. THE PROCEDURE WAS CARRIED OUT BY OVERLAPPING THE BALLOON BY AT LEAST 3CM AND EXTENDING THE DCB (DRUG COATED BALLOON) BY AT LEAST 1CM BEYOND THE LESION BOTH PROXIMALLY AND DISTALLY. IT WAS REPORTED 365 POST PROCEDURE THE PATIENT WAS TREATED FOR RESTENOSIS OF THE SAME VESSEL.

  Patient problems: Reocclusion

  MAUDE report 8077844 ↗
• MalfunctionSep 11, 2018Leak/Splash; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE A IN.PACT ADMIRAL A 5FR SHEATH & A 0.035 NON-MDT GUIDEWIRE TO TREAT AN 120MM SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY OF 4MM IN DIAMETER. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS INFLATED USING A NON-MDT INFLATION DEVICE. IT WAS REPORTED THAT DURING THE FIRST INFLATION TO 8ATM BALLOON INFLATION DIFFICULTIES WERE ENCOUNTERED AND A BALLOON LEAK WAS OBSERVED. THE BALLOON APPEARED INTACT UPON REMOVAL, BLOOD RETURNED INTO THE INFLATION DEVICE DURING DEFLATION OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING AN EVERCROSS BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7863603 ↗
• MalfunctionJun 13, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED AN IN.PACT ADMIRAL WITH A 6 FR NON-MEDTRONIC SHEATH AND SPIDER FX EMBOLIC PROTECTION DEVICE FOR THE TREATMENT OF A 100MM LESION IN THE PATIENT'S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY <(>&<)> POPLITEAL ARTERY. THE VESSEL WAS NOTED TO HAVE A DIAMETER OF 4MM, OF LITTLE TORTUOSITY AND CALCIFICATION OF 20%. THE TARGET LESION (DISTAL SFA) EXHIBITED 90% STENOSIS PRIOR TO DIRECTIONAL ATHERECTOMY, USING A HAWK, LEAVING 20-30% RESIDUAL STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 70/30 CONTRAST NS. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NEGATIVE PRESSURE WAS PERFORMED BEFORE INFLATING. THE BALLOON WAS INFLATED TO A PRESSURE OF 8ATMS AND IT WAS NOTED THE BALLOON WOULD NOT REMAIN INFLATED. A NEW IN.PACT ADMIRAL DEVICE OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7595410 ↗
• MalfunctionJan 12, 2018Deflation Problem; Deflation Problem

  PHYSICIAN USED AN IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER WITH AN .014 GW, 6FR SHEATH AND A NON-MDT INFLATION DEVICE FOR THE TREATMENT OF A SLIGHTLY CALCIFIED PLAQUE LESION IN THE PROXIMAL SFA. LESION EXHIBITED 50% STENOSIS. EMBOLIC PROTECTION WAS NOT USED. DEVICE PREPPED AS PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THIS OCCURRED AFTER THE BALLOON WAS SUCCESSFULLY INFLATED 3 TIMES FOR 3 MINUTES AT EACH INFLATION. PHYSICIAN SUCCESSFULLY PARTIALLY DEFLATED THE BALLOON AND PULLED IT BACK THROUGH THE SHEATH FOR REMOVAL FROM THE PATIENT. NO OTHER INTERVENTION WAS REQUIRED. IT WAS REPORTED THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7188557 ↗