IN.PACT™ Admiral™ ADM04025013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169975064), received between Jul 27, 2021 and May 15, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Deflation Problem

  IT WAS REPORTED THAT A DRUG COATED BALLOON CATHETER WAS USED DURING A PERIPHERAL ARTERY PROCEDURE INVOLVING A PLAQUE LESION IN THE MID LEFT POPLITEAL ARTERY (LESION LENGTH 250 MM; VESSEL DIAMETER 4 MM) AND DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE WITH 50/50 CONTRAST. DURING ATTEMPTED REMOVAL, THE BALLOON WAS NOT EVENTUALLY FULLY DEFLATED AND NEGATIVE PRESSURE WAS REQUIRED; IT WAS REPORTED THAT THE BALLOON DEFLATED WHEN IT WAS PULLED THROUGH THE SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTIONS AS IT WAS THE END OF THE CASE.  NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182528 ↗
• MalfunctionJan 26, 2023Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE AN IMPACT ADMIRAL DRUG COATED BALLOON WITH A 6FR NON-MEDTRONIC (COOK) SHEATH AND A 5MM SPIDER FX GUIDEWIRE/EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 300MM FIBROUS PLAQUE LESION IN PATIENTS RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) & POPLITEAL ARTERY. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 4MM. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST MIX INFLATION FLUID WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED ON SECOND INFLATION. NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. THERE WERE NO ISSUES NOTED DURING INFLATION. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL AFTER APPROX. 1-2 MIN THROUGH CONTINUOUS NEGATIVE PRESSURE WAS USED TO COMPLETE PROCEDURE. N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245298 ↗
• MalfunctionJul 27, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE INPACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER DURING PROCEDURE TO TREAT A PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) TO POPLITEAL ARTERY. THE VESSEL DIAMETER AND LESION LENGTH ARE 4MM AND 250MM RESPECTIVELY. A N ON-MEDTRONIC INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST , LEAK OR RUPTURE OCCURRED. BALLOON INFLATION DIFFICULTY WAS NOTED DURING BALLOON INFLATION. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231402 ↗