IN.PACT™ Admiral™ ADM06020013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169975026), received between Oct 3, 2019 and Sep 3, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 reports).

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.

• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT ADMIRAL BALLOON WAS USED TO TREAT THE RIGHT SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 25 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOSIS OF RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL. PATIENT HAD FOLLOW-UP WITH VASCULAR GROUP FOR LEFT LEG. REPORTING RIGHT LEG PAIN. ULTRA SOUND COMPLETED AND NOTING RIGHT SUPERFICIAL FEMORAL ARTERY STENTS WERE OCCLUDED THEREFORE SCHEDULED FOR PROCEDURE. PATIENT HAD THE FOLLOWING COMPLETED: RIGHT FEMORAL ENDARTERECTOMY, RIGHT SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY, POPLITEAL ANGIOPLASTY AND STENTING, RIGHT COMMON ILIAC ANGIOPLASTY AND STENTING, RIGHT EXTERNAL ILIAC ANGIOPLASTY AND STENTING, RIGHT EXTERNAL ILIAC ANGIOPLASTY AND STENTING (RIGHT: LEG) WHICH INVOLVED TARGET LESIONS. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 22955821 ↗
• MalfunctionDec 12, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN INPACT ADMIRAL DRUG COATED BALLOON, THE BALLOON BURST AT A NOMINAL PRESSURE OF 5 ATM ON THE FIRST INFLATION. THE PROCEDURE WAS CONDUCTED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY, MID-SECTION, WHICH HAD A CALCIFIED LESION WITH MODERATE CALCIFICATION AND 90% STENOSIS. THE LESION LENGTH WAS 180 MM, AND THE ARTERY DIAMETER WAS 6 MM. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE VESSEL WAS PRE-DILATED USING A 5X150 NON-MEDTRONIC DEVICE. A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST INFLATION FLUID. THE BALLOON BURST OCCURRED DURING THE PROCEDURE. THE BALLOON DID NOT DETACH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW INPACT ADMIRAL DEVICE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918241 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL 1 SEGMENT (R1). APPROXIMATELY 17 DAYS POST PROCEDURE THE PATIENT SUFFERED FROM A LEFT GROIN PSEUDOANEURYSM AT THE SITE OF THE INDEX PROCEDURE ACCESS. THE EVENT WAS SUCCESSFULLY TREATED WITH A PERCUTANEOUS THROMBIN INJECTION. THE PATIENT RECOVERED.

  Patient problems: Pseudoaneurysm

  MAUDE report 17629976 ↗
• MalfunctionJan 22, 2023Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTED TO USE TWO IN PACT ADMIRAL BALLOONS FOR TREATMENT OF A 200MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID LEFT REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE DEGREE OF CALCIFICATION WAS SEVERE AND TORTUOSITY WAS MODERATE. THE ARTERY DIAMETER WAS 6MM. A 6FR SHEATH AND 035 GUIDEWIRE WERE USED. NO Y DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM PACKAGING. THE BALLOONS WERE INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE DEVICES WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED.  INFLATION FLUID WAS 60% NORMAL SALINE 40% CONTRAST. IT WAS REPORTED DURING THE FIRST BALLOON INFLATION THAT A PINHOLE BURST OCCURRED, IT WAS REPORTED THE INFLATION PRESSURE COULD NOT GET TO NOMINAL 5. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. ANOTHER BALLOON WAS USED AND DURING THE FIRST ATTEMPT OF INFLATION A PINHOLE BURST WAS OBSERVED AT 8ATM. THERE WERE NO FRAGMENTS PRESENT. THE CALCIUM PUNCTURED THE BALLOONS DURING INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED. THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221615 ↗
• MalfunctionAug 11, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN INPACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER WITH A 55MM 7FR SHEATH, A NON-MEDTRONIC GUIDEWIRE AND A 7MM SPIDER FX EMBOLIC PROTECTION DEVICE DURING A PROCEDURE TO TREAT A 8CM CALCIFIED LESION IN THE PATIENTS MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 50% STENOSIS. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT DURING BALLOON INFLATION, A BALLOON BURST OCCURRED AT 8 ATM. ALL FRAGMENTS OF THE DEVICE WERE RETRIEVED. ANGIOPLASTY AND A SECOND INPACT ADMIRAL WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209478 ↗
• MalfunctionOct 3, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS USING AN IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SFA. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES 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, IT BURST AT 9ATM. ALL BALLOON FRAGMENT WAS REMOVED FROM PATIENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE ONCE REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150335 ↗

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