IN.PACT™ Admiral™ ADM05015013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169576339), received between Apr 13, 2017 and Mar 14, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE IN.PACT ADMIRAL DRUG COATED BALLOON, A LONGITUDINAL BALLOON BURST OCCURRED IN THE SUPERFICIAL FEMORAL ARTERY ON THE RIGHT SIDE AT THE MID-LOCATION DURING THE FIRST INFLATION. THE TARGET LESION WAS DESCRIBED AS CALCIFIED. IT IS NOT KNOWN AT WHAT PRESSURE THE BALLOON BURST.  A 6FR NON MEDTRONIC SHEATH WAS USD. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED EVERFLEX, NO RESISTANCE WAS MET. THE PROCEDURE WAS ABORTED AS A RESULT OF THE BALLOON BURST. THE BALLOON DID NOT DETACH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND NO INJURY OR INTERVENTION WAS ASSOCIATED WITH THE EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604497 ↗
• InjuryOct 17, 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 POPLITEAL ARTERY. APPROXIMATELY 8 MONTHS POST PROCEDURE, PATIENT SUFFERED CRITICAL LIMB ISCHEMIA WHICH WAS TREATED WITH THE REVASCULARIZATION OF THE LEFT POPLITEAL USING A PTA BALLOON CATHETER. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Injury

  MAUDE report 9201023 ↗
• InjuryAug 20, 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 MID SFA AND ONE INPACT ADMIRAL BALLOON CATHETER WAS USED TO TREAT THE RIGHT DISTAL SFA. APPROX 1 YEAR POST INDEX PROCEDURE THE PATIENT SUFFERED RIGHT SFA OCCLUSION. 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: Occlusion

  MAUDE report 8909314 ↗
• MalfunctionMay 9, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN USED A BALLOON ON 100% STENOSIS WITHIN A STENT IN THE DISTAL SUPERFICIAL FEMORAL ARTERY(SFA). THE LESION WAS DESCRIBED AS A CHRONIC TOTAL OCCLUSION(CTO) OF 150MM IN LENGTH OF SOFT TISSUE, PLAQUE WITH SLIGHT CALCIFICATION AND SLIGHT TORTUOUSITY IN AN ARTERY OF DIAMETER OF 5MM. THIS WAS THEN FOLLOWED BY ATHERECTOMY. THE PHYSICIAN THEN WANTED TO USE AN INPACT ADMIRAL DCB BALLOON. 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 0.014 NITREX GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. 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. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE TO 8ATM. IT WAS REPORTED THAT THE INPACT ADMIRAL WAS LEAKING PRESSURE. THE BALLOON AND ALL FRAGMENTS WERE REPORTED TO HAVE BEEN RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8594583 ↗
• MalfunctionMar 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN INPACT ADMIRAL BALLOON TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS PLAQUE 80-90% STENOTIC LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 5-6MM <(>&<)> 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 0.014NON-MEDRONIC HYDRO WIRE WERE USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED TO 8ATM WITH A NON-MEDTRONIC INFLATION DEVICE AND 60/40 HEP SALINE/OMNIPAQUE SOLUTION USED AS INFLATION FLUID. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS ENCOUNTERED BUT NO EXCESSIVE FORCE WAS USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE INPACT ADMIRAL BALLOON WAS INFLATED BUT IT DID NOT HOLD PRESSURE. THE BALLOON WAS VISUALIZED WITH NO ABNORMALITY UNDER FLUOROSCOPY. PRESSURE WAS CONTINUED FOR 40SECONDS. THE DEVICE DEFLATED AND WAS REMOVED WITHOUT ANY DIFFICULTY. UPON REMOVAL IT WAS INFLATED AND A PINHOLE LEAK WAS OBSERVED. AN ADDITIONAL 5X150 INPACT ADMIRAL BALLOON F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386176 ↗
• MalfunctionFeb 28, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE AN IMPACT ADMIRAL DRUG ELUTING BALLOON TO TREAT A CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY WITH MODERATE TORTUOSITY IN A PATIENT. A NON MEDTRONIC (BOSTON SCIENTIFIC) INFLATION DEVICE AND GUIDEWIRE (COOK) WAS USED. CONTRAST AND SALINE WERE USED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU. IT WAS REPORTED THAT A BALLOON A PIN HOLE BURST OCCURRED DURING INFLATION AT 8-14 ATMS. ONE INFLATION THAT REQUIRED CONSTANT ADDITIONS AS PRESSURE DEGRADED (ADDED PRESSURE TO MAINTAIN SIZE AND PRESSURE). ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377282 ↗
• 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 8077900 ↗
• MalfunctionOct 30, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE IN.PACT ADMIRAL TO TREAT A LESION IN THE MID POPLITEAL ARTERY WITH NO TORTUOSITY, CALCIFICATION AND 60% STENOSIS AS PER IFU. A NON-MEDTRONIC INFLATION DEVICE ALONG WITH A 6F SIZE SHEATH <(>&<)> A NON-MEDTRONIC GUIDEWIRE WERE USED. NEGATIVE PREP WAS PERFORMED WITH NO ABNORMALITIES NOTED. THE LESION WAS PREPPED WITH ATHERECTOMY. NO RESISTANCE OR EXCESSIVE FORCE WAS USED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED DURING THE PROCEDURE THE PHYSICIAN ENCOUNTERED INFLATION DIFFICULTIES AT 8ATM. THE BALLOON WOULD NOT EXPAND TO IT PROPER SIZE. NO LEAKAGE OF CONTRAST WAS NOTED ON THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8018414 ↗
• MalfunctionMar 8, 2018Leak/Splash; Leak/Splash

  PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL DEVICE WITH A NON-MDT SHEATH (6F), NON-MDT .035 GUIDEWIRE AND NON-MDT INFLATION DEVICE FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL DESCRIBED S BEING MODERATELY TORTUOUS. LESION STENOSIS UNKNOWN. 50/50 CONTRAST/SALINE INFLATION FLUID WAS USED. IT IS REPORTED THE TECH DOES NOT RECALL THE DEVICE PASSING THROUGH A PREVIOUSLY DEPLOYED STENT, NOR WAS THERE ANY EXCESSIVE RESISTANCE ENCOUNTERED. NEGATIVE PREP WAS NOT PERFORMED OUTSIDE THE BODY. WHEN NEGATIVE PREP WAS ATTEMPTED INSIDE OF THE PATIENT, A BALLOON BURST, LEAK OR RUPTURE OCCURED AND BLOOD RETURN WAS NOTICED IN THE INFLATION DEVICE. THE BALLOON DID NOT INFLATE. A NEW IN.PACT ADMIRAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323449 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD TWO PROCEDURES FIRST ON (B)(6) 2017 FOR THE RIGHT SFA, AND SECOND ON (B)(6) 2017 FOR THE LEFT SFA/POPLITEAL. BOTH CASES USED CSI ORBITAL ATHERECTOMY FOLLOWED BY IN.PACT ADMIRAL. BILATERAL RASH BELOW THE KNEES TO THE ANKLE OCCURRED 3 DAYS POST SECOND PROCEDURE. SHE HAD BLISTERS OVER THE ANTERIOR SURFACE OF HER BILATERAL LOWER EXTREMITIES WITH DEVELOPING ERYTHEMA AND PAIN. THE BLISTERS POPPED AND THEN HAD SKIN SLOUGHING AND DRYNESS. SHE HAS CONTINUED PAIN WHICH HAS WORSENED TO THE POINT THAT WHEN SHE MOVES TO WALK OR EVEN LIFT HER LEGS UP IT STRETCHES THE SKIN AND HAS SHOOTING PAIN. THE PATIENT DENIES CHEST PAIN, SOB, ABDOMINAL PAIN, NAUSEA, VOMITING, DIARRHEA OR CONSTIPATION. PATIENT PRESENTED TO ER WITH A RED AND SWOLLEN RLE WITH SEVERE PAIN. WHEN THE PATIENT WALKS, SHE HAS BLE LEG PAIN, RIGHT>LEFT. AN ULTRASOUND OF HER LOWER EXTREMITIES WAS NEGATIVE FOR DEEP VENOUS THROMBOSIS. THE PATIENT DID RECEIVE A DRUG ELUTING STENT WITH PACLITAXEL. PATIENT IS IN NEED OF BILATERAL KNEE SURGERY, BUT NOT A CANDIDATE DUE TO PAD. LE DUPLEX REVEALED SEVERE DISEASE OF THE RIGHT SFA, TPT AND AN OCCLUDED AT. PATIENT HAS A MILD DISEASE AT THE PRIOR LEFT POPLITEAL PTA SITE AND AN OCCLUD

  Patient problems: Reaction

  MAUDE report 6629516 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL ILIAC STENTS. 3 IN.PACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE LESION IN THE POPLITEAL TO POPLITEAL/TIBIAL TRUNK. PROTEGE STENT WAS IMPLANTED IN THE ILIAC ARTERY TO COMPLETE THE PROCEDURE. PHYSICIAN FLIPPED PATIENT OVER AND ACCESSED THE POPLITEAL ARTERY TO DELIVER THE DCB INTO THE SFA. PATIENT HAD JUST RECENTLY HAD SHINGLES. DR. (B)(6) WAS THE PHYSICIAN THAT DID THE PROCEDURE BUT SALES REP WAS CONTACTED BY DR. (B)(6) THE FOLLOWING WEEK. PATIENT HAD SHINGLES PRIOR TO THIS BUT PHYSICIAN SAID THE RASH WAS DIFFERENT THAN THE SHINGLES. THE SFA MID TO DISTAL WAS TREATED THROUGH POPLITEAL ACCESS HOWEVER NO RASH OCCURRED ON THIS PORTION OF LEG IT WAS ALL DISTAL TO AREA TREATED. PATIENT WAS TREATED WITH STEROIDS. STEROID WAS DELIVERED ORALLY STEROID DOSE PACK

  Patient problems: Reaction

  MAUDE report 6489255 ↗

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