IN.PACT™ Admiral™ ADM06006013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169383265), received between Jul 12, 2017 and Apr 6, 2021 — classified as 1 death, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 6, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN USED AN INPACT ADMIRAL DRUG COATED BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 40MM PLAQUE LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY, POSTERIOR TIBIAL ARTERY, AND ANTERIOR TIBIAL ARTERY. ARTERY DIAMETER REPORTED AS 6MM. SLIGHT VESSEL CALCIFICATION REPORTED. SEVERE ILIACS TORTUOSITY ,ALMOST 90 DEGREE COMMON -EXTERNAL ILIAC CONNECTION REPORTED RELATED TO THE PATIENT¿S ANATOMY. LESION EXHIBITED 70% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE AS USED WITH 50/50 INFLATION FLUID FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. MEDIUM RESISTANCE WAS NOTED WHEN ADVANCING THE BALLOON INTO THE 6FR SHEATH ON RIGHT GROIN UP AND OVER AND DELIVERING IT TO THE LEFT PROXIMAL LEFT SFA. THE LEFT ILIACS WERE ALMOST SHAPED IN TWO RIGHT ANGLES. THE PHYSICIAN APPLIED EXCESSIVE FORCE TO PUSH THE BALLOON FORWARD. POST DILATION THE PHYSICIAN BEGAN PULLING THE BALLOON BACK INTO THE SHEATH PLACED IN THE LEFT COMMON FEMORAL ARTERY. THE BALLOON STOPPED MOVING BACKWARD WHEN IT WAS HALFWAY INTO

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11617755 ↗
• DeathApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, AN IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER WAS USED TO TREAT THE LEFT DISTAL SFA. APPROXIMATELY 9 MONTHS POST PROCEDURE, SEVERE AORTIC VALVE STENOSIS WAS REPORTED WHICH WAS TREATED WITH MEDICATION. PATIENT DIED A MONTH LATER ((B)(6) 2019). DEATH WAS CLASSIFIED AS CARDIAC DEATH. INVESTIGATOR AND SAFETY ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE AND PACLITAXEL.

  Patient problems: Death

  MAUDE report 8508144 ↗
• 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 8415749 ↗
• MalfunctionSep 13, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE AN IN.PACT ADMIRAL PACLITA DRUG ELUTING BALLOON TO TREAT A SEVERELY CALCIFIED PROXIMAL SFA LESION. THE LESION WAS 100 MM IN LENGTH WITH 70% STENOSIS. THE ARTERY DIAMETER IS 6 MM WITH NO TORTUOSITY. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU. NO EMBOLIC PROTECTION WAS USED. THE IN.PACT ADMIRAL PACLITA DRUG ELUTING BALLOON WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. NO EXCESSIVE FORCE WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE BALLOON BURST AT 8 ATMS ON THE FIRST INFLATION. THE PHYSICIAN COMPLETED THE PROCEDURE USING A FORTREX BALLOON AND PLACING A COVERED STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6863175 ↗
• MalfunctionAug 15, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE ONE INPACT ADMIRAL BALLOON TO TREAT A MODERATELY CALCIFIED AND TORTUOUS MID RIGHT SFA PLAQUE LESION EXHIBITING 75% STENOSIS. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND PREPPED PER THE IFU - ON INSPECTION, NO ISSUES WERE NOTED. A NON-MDT INFLATION DEVICE WAS USED. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE LESION WAS PREDILATED. NO RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT AT 8ATM IT WAS NOTED THAT THE BALLOON COULD NOT MAINTAIN PRESSURE DESPITE TRYING TO CONSTANTLY INFLATE THE BALLOON. THE PHYSICIAN THEN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE USING A NON-MDT STENT. DESPITE BEING UNABLE TO MAINTAIN ATM PRESSURE, THE PHYSICIAN WAS HAPPY WITH THE VESSEL OUTCOME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6795826 ↗
• MalfunctionAug 11, 2017Leak/Splash; Leak/Splash

  IN.PACT ADMIRAL WAS USED AS PER IFU IN THE PROXIMAL LEFT COMMON FEMORAL ARTERY WITH A DIAMETER OF 7MM, TO TREAT A 60MM LONG LESION WITH 20% STENOSIS , LITTLE CALCIFICATION, NO TORTUOSITY OR RESISTANCE ENCOUNTERED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUE NOTED, THE LESION WAS PRE-DILATED. IT WAS REPORTED DURING THE PROCEDURE THE BALLOON WAS INFLATED SLOWLY, AT 12ATM¿S A CIRCUMFERENTIAL BALLOON BURST WAS OBSERVED AT FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT OVER THE WIRE ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING AN EVERCROSS BALLOON WITH NO FURTHER ISSUES NOTED. NO PROCEDURAL IMAGES AVAILABLE FOR REVIEW. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6790252 ↗
• InjuryJul 12, 2017Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS USING A 6X60 IN.PACT ADMIRAL DCB BALLOON, ON INFLATION THE DCB BURST AT 4 ATM. IT SHOULD BE NOTED THAT A 5MM BOSTON MUSTANG PTA BALLOON ALSO BURST WITH ONE DILATION DUE TO HEAVY CALCIFICATION WITHIN THE COMMON ILIAC ARTERY. THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. PHYSICIAN WAS TREATING A SEVERELY CALCIFIED LESION IN THE ILIAC ARTERY WITH AN ARTERY DIAMETER OF 6 MM. THERE WAS NO TO PATIENT OR CLINICAL SEQUELAE. THE LESION WAS PRE DILATED WITH A 5MM BOSTON MUSTANG PTA BALLOON WHICH ALSO BURST. THE PATIENTS COMMON ILIA ARTERY WAS NOTED TO BE SEVERELY CALCIFIED. NO PATIENT INJURY REPORTED

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6706443 ↗