IN.PACT™ Admiral™ ADM06025013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169975088), received between Feb 5, 2019 and Sep 15, 2025 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE MID AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY, THE IN. PACT ADMIRAL EACH BURST AT 2 ATM PRESSURE ON THE FIRST INFLATION. THE VESSEL WAS PRE-DILATED PRIOR TO USE OF BOTH DEVICES, AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING EITHER DEVICE. THERE WERE NO ABNORMALITIES IN ANATOMY. THE BALLOONS DID NOT DETACH DURING THE EVENT, AND BOTH DEVICES WERE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048847 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE IN. PACT ADMIRAL WAS USED TO TREAT THE LEFT SUPERFICIAL FEMORAL PROXIMAL LESION. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED TARGET LESION LEFT SUPERFICIAL FEMORAL ARTERY (SFA) RESTENOSIS. SUBJECT HAD ARTERIAL ULTRASOUND SHOWING NEW BLOCKAGE IN LEFT LEG. ANGIOGRAM RECOMMENDED AND COMPLETED. 99% RESTENOSIS IN INDEX TARGET LESION LEFT SFA AND 80% IN-STENT RESTENOSIS (ISR) IN RIGHT SFA. SUCCESSFUL SFA TREATMENT. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21643051 ↗
• InjuryMar 20, 2024Adverse 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. PATIENT SUFFERED DISSECTION. PROVISIONAL/BAIL-OUT STENTING WITH A NON-MEDTRONIC DEVICE WAS DONE TO TREAT THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 18942581 ↗
• InjuryMar 20, 2024Adverse 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. PATIENT SUFFERED DISSECTION. PROVISIONAL/BAIL-OUT STENTING WITH A NON-MEDTRONIC DEVICE WAS DONE TO TREAT THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 18942549 ↗
• MalfunctionJan 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A IN.PACT ADMIRAL TO TREAT A SOFT TISSUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS MODERATE. A 6F ARROW WAS USED. A V18 GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. DURING REMOVAL OF THE BALLOON POST INFLATION, BALLOON CAME OFF SHAFT ON GOT STUCK IN THE SHEATH. TECH CLAMPED DOWN ON THE PROXIMAL END OF SHEATH BECAUSE THAT IS WHERE BALLOON CAME OFF SHAFT AND REMOVED EVERYTHING ALL TOGETHER. NO DETACHED PORTION OF DEVICE REMAINED IN PATIENT. TO COMPLETE PROCEDURE 6F SLIM SLENDER SHEATH WAS EXCHANGED THEN FOLLOWED BY A UNKNOWN CLOSURE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484614 ↗
• MalfunctionAug 4, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE AN INPACT ADMIRAL DRUG COATED BALLOON WITH A 6FR NON-MEDTRONIC (TERUMO DESTINATION) SHEATH AND A 0.014 6MM SPIDER FX EMBOLIC PROTECTION/GUIDEWIRE DURING TREATMENT OF A 300MM CALCIFIED LESION IN THE PATIENTS LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION AND LITTLE VESSEL TORTUOSITY ARE REPORTED. ARTERY DIAMETER IS REPORTED AS 6MM. LESION EXHIBITED 85% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A SALINE/CONTRAST MIX WAS USED FOR INFLATION FLUID. 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. EXCESSIVE FORCE WAS NOT USED. ATHERECTOMY WAS PERFORMED USING HAWKONE M OVER .014 6MM SPIDER FX WIRE. PHYSICIAN THEN ATTEMPTED TO COMPLETED TREATMENT WITH DCB. UPON ATTEMPTING TO INFLATE THE 6X250 INPACT ADMIRAL DCB, PHYSICIAN COULD NOT INFLATE PAST 3ATMS. A SEPARATE INFLATION DEVICE WAS OPENED AND ATTEMPTED, WITH SIMILAR RESULTS. BALLOON WAS THEN DEEMED TO BE LIKEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17458052 ↗
• InjuryApr 14, 2023Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component; Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component

  A PHYSICIAN WAS USING AN IN.PACT ADMIRAL FOR THE TREATMENT OF A 120MM CALCIFIED LESION WITH 75% STENOSIS IN THE PROXIMAL/MID SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER WAS 6.0-6.6MM WITH MILD TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WAS USED. AN INFLATION DEVICE WITH CONTRAST FLUID WAS USED FOR INFLATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED DEVICE AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT WAS REPORTED THE BALLOON BURST LONGITUDINALLY AT 11 ATM AFTER ONE PRIOR INFLATION. THE BALLOON WOULD NOT DEFLATE AND THE IN PACT ADMIRAL CATHETER SNAPPED, LEAVING 20CM OF BALLOON CATHETER INSIDE THE PATIENT. VESSEL PERFORATION OCCURRED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A CUT DOWN.

  Patient problems: Perforation

  MAUDE report 16741035 ↗
• MalfunctionMar 24, 2023Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE AN IN.PACT ADMIRAL DURING TREATMENT OF A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER WAS 6MM. THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH WAS USED. INFLATION DEVICE WAS USED. SALINE/CONTRAST WAS USED AS INFLATION FLUID. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE FIRST INFLATION THE BALLOON RUPTURED LONGITUDINALLY AT 8ATM. ALL FRAGMENTS WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED.  ANOTHER BALLOON WAS USED TO COMPLETE THE CASE. NO VESSEL INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613651 ↗
• MalfunctionFeb 10, 2023Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED THAT DURING A PROCEDURE AN IMPACT ADMIRAL BALLOON RUPTURED DURING INFLATION. THE PRESSURE AT TIME OF RUPTURE UNKNOWN. MAX INFLATION PRESSURE 5 ATM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16348850 ↗
• MalfunctionNov 14, 2022Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE AN IN. PACT ADMIRAL DRUG-COATED BALLOON FOR TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE MID/DISTAL REGION OF THE SUPERFICIAL FEMORAL AND ARTERY POPLITEAL ARTERY. THE ARTERY HAD MODERATE TORTUOSITY AND CALCIFICATION. A SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. THE DCB WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT A LONGITUDINAL BURST OCCURRED AT 3-5 ATM. ALL FRAGMENTS WERE RETRIEVED. SPIDER WAS REMOVED. .035 WIRE INSERTED. ANOTHER 035 INPACT ADMIRAL WAS USED WITH NO ISSUE OVER THE .035 WIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789502 ↗
• MalfunctionMar 11, 2022Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE INPACT ADMIRAL DCB DURING PROCEDURE TO TREAT A CALCIFIED LESION IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUE IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, A CIRCUMFERENTIAL OR RADIAL BURST OCCURRED. THIS CAUSED REMOVAL DIFFICULTIES, WITH DIFFICULTY TO REMOVING BALLOON FOLLOWING BALLOON INFLATION. IT WAS REPORTED THAT DUE TO SITE OF RUPTURE, IT WAS DIFFICULT TO REMOVE ALL CONTRAST FROM DISTAL END. PHYSICIAN HAD TO PULL THE PROXIMAL END BACK INTO THE SHEATH FIRST, THEN PULLED NEGATIVE TO REMOVE THE CONTRAST FROM DISTAL END, THEN WAS ABLE TO REMOVE THE BALLOON. IT IS UNKNOWN AT WHAT PRESSURE THE BALLOON BURST. THERE WAS NO VESSEL DAMAGE REPORTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13731290 ↗
• MalfunctionJan 15, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  THE PHYSICIAN ATTEMPTED TO USE AN IN.PACT ADMIRAL DCB DEVICE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT DURING BALLOON INFLATION, INFLATION DIFFICULTIES OCCURRED. THE BALLOON NEVER HELD PRESSURE AT 8 ATM. BALLOON PIN-HOLE WAS IDENTIFIED WHEN DEVICE WAS TESTED IN VITRO. THERE WAS NOT BALLOON BURST BUT A BALLOON LEAK. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591431 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED THE IMPACT ADMIRAL WITH A 6F COOK SHEATH, SPIDER FX AND COOK INFLATION DEVICE WITH 50/50 CONTRAST TO TREAT A CALCIFIED PLAQUE SOFT TISSUE CTO, WITH LITTLE CALCIFICATION AND NO VESSEL TORTUOSITY, IN THE MID SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE BALLOON WAS INFLATED TO 6ATM WHEN A PERFORATION IN THE SUPERFICIAL FEMORAL ARTERY OCCURRED, THE PERFORATION WAS TREATED WITH A POBA TAMPONADE AND COVERED WITH BARE METAL STENTING. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Perforation

  MAUDE report 8310033 ↗
• MalfunctionFeb 5, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS INTENDING TO USE AN INPACT ADMIRAL TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO ISSUES REPORTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT WAS REPORTED THAT DURING BALLOON INFLATION TO 10ATM, A LONGITUDINAL BALLOON BURST OCCURRED. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304516 ↗

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