IN.PACT™ Admiral™ ADM04020013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169975002), received between Feb 3, 2022 and Jan 19, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P140010); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL BALLOONS WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. APPROXIMATELY 3 YEARS 5 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA. OCCLUDED MID-FEMORAL TO MID POPLITEAL STENT (LEFT LEG) TREATED WITH ATHERECTOMY, PLAIN OLD BALLOON ANGIOPLASTY, DRUG COATED BALLOON. THE EVENT WAS ALSO TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 24109198 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 IN.PACT ADMIRAL BALLOONS WERE USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. A 3RD IN.PACT ADMIRAL BALLOON WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 4 YEARS AND 1 MONTH POST PROCEDURE PATIENT SUFFERED LEFT LOWER EXTREMITY CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL AND NON-TARGET LESION/VESSEL. OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY, POPLITEAL, PERONEAL, POSTERIOR TIBIAL AND ANTERIOR TIBIAL ARTERIES. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 22963583 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN. PACT ADMIRAL BALLOONS WERE USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. APPROXIMATELY 33 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL. PATIENT WAS TREATED WITH PERCUTANEOUS INTE RETENTION. TOTALLY OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) (TARGET LESION), SUB TOTALLY OCCLUDED MID P2 SEGMENT (TARGET LESION), TOTALLY OCCLUDED ANTERIOR/POSTERIOR TIBIAL ARTERY. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 21739556 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL BALLOONS WERE USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT AND POPLITEAL 2 SEGMENT. APPROXIMATELY 36 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL AND NON-TARGET LESION/VESSEL. OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA), LEFT POPLITEAL (TARGET LESION), LEFT ANTERIOR TIBIAL AND PERONEAL ARTERIES (NON-TARGET LESIONS). PATIENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion; Stenosis

  MAUDE report 21739230 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE COMMON FEMORAL ARTERY, THE PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND THE POPLITEAL 1 AND POPLITEAL 2 SEGMENTS. APPROXIMATELY 9 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM SEVERE LEFT LEG CLAUDICATION (LEFT COMMON FEMORAL, SFA AND POPLITEAL ARTERIES RESTENOSIS). THE EVENT WAS TREATED WITH A TARGET LESION REVASCULARIZATION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS PROBABLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Pain; Stenosis

  MAUDE report 16476459 ↗
• MalfunctionFeb 3, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE THE IN.PACT ADMIRAL DCB DURING PROCEDURE TO TREAT MODERATELY CALCIFIED PLAQUE IN THE MID DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA).THE VESSEL HAD MODERATE TORTUOSITY. THE ARTERY DIAMETER WAS 4MM AND LESION LENGTH WAS 250MM. A NON MEDTRONIC 6FR SHEATH AND GUIDEWIRE WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUE WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED. THE BALLOON WAS INFLATED WITH A BALLOON INFLATION DEVICE AS PER IFU. IT WAS REPORTED THAT THERE SEEMED TO BE A HOLE IN THE BALLOON AS IT WOULD NOT HOLD PRESSURE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SIZED IN.PACT BALLOON WITH NO ISSUES. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442291 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140010. One submission often covers many models, so check the product and lot details in each record.

• Z-1042-2022 · Mar 23, 2022 · Open, Classified
  Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM040120