IN.PACT™ Admiral™ ADM06004013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169383258), received between Jun 7, 2017 and May 15, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS REQUIRING REPEAT TREATMENT OCCURRED IN A PATIENT WITHIN 12 MONTHS AFTER A PROCEDURE USING AN INPACT ADMIRAL DRUG COATED BALLOON. INITIAL TREATMENT WAS (B)(6) 2025. NO EMBOLIC PROTECTION WAS USED, AND THE BALLOON WAS INFLATED USING AN INFLATION DEVICE. A NEW 6X40 INPACT AV DRUG COATED BALLOON WAS USED TO RE-TREAT AND COMPLETE THE PROCEDURE.

  Patient problems: Restenosis

  MAUDE report 25184139 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH TWO IN.PACT AV ACCESS BALLOON AND TWO NON MDT BALLOONS. DURING A FOURTH PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING TWO NON MDT BALLOONS. DURING A FIFTH PROCEDURE THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT ADMIRAL BALLOON AND FOUR NON MDT BALLOONS. DURING A SIXTH PROCEDURE, THE IN CANNULATION ZONE OF THE LEFT ARM WAS TREATED WITH 6 NON MDT BALLOONS. DURING A SEVENTH PROCEDURE, THE CENTRAL VEIN OF THE LEFT ARM WAS TREATED WITH TWO NON MDT BALLOONS. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE, 14 MONTHS POST THE SECOND PROCEDURE, 11 MONTHS POST THE THIRD PROCEDURE, 10 MONTHS POST THE FOURTH PROCEDURE, 7 MONTH POST THE FIFTH PROCEDURE, 6 MONTHS POST THE SIXTH PROCEDURE AND 3 MONTHS POST THE SEVENTH PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE PATIENT PRESENTED FOR A ROUTINE FISTULOGRA

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17779635 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE INPACT AV ACCESS BALLOON WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH TWO INPACT AV ACCESS BALLOON AND TWO NON MDT BALLOONS. DURING A FOURTH PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING TWO NON MDT BALLOONS. DURING A FIFTH PROCEDURE THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM WERE TREATED WITH ONE INPACT ADMIRAL BALLOON AND FOUR NON MDT BALLOONS. DURING A SIXTH PROCEDURE, THE IN CANNULATION ZONE OF THE LEFT ARM WAS TREATED WITH 6 NON MDT BALLOONS. APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE, 11 MONTHS POST THE SECOND PROCEDURE, 8 MONTHS POST THE THIRD PROCEDURE, 7 MONTHS POST THE FOURTH PROCEDURE, 4 MONTH POST THE FIFTH PROCEDURE AND 3 MONTHS POST THE SIXTH PROCEDURE, THE PATIENT SUFFERED FROM CENTRAL VEIN RESTENOSIS OF THE AV FISTULA. THE PATIENT PRESENTED FOR A ROUTINE FISTULAGRAM. THE IMAGING SHOWED 90% RESTENOSIS OF THE CENTRAL VEIN (NON INDEX LESION). THE EVENT WAS SUCCESSFULLY TREATED WITH A HIGH PRESSURE AND

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17772306 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT AV ACCESS BALLOON AND ONE NON MDT BALLOON EACH. DURING A FOURTH PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING TWO NON MDT BALLOONS. DURING A FIFTH PROCEDURE THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT ADMIRAL BALLOON AND FOUR NON MDT BALLOONS. APPROXIMATELY 11 MONTHS POST THE INDEX PROCEDURE, 8 MONTHS POST THE SECOND PROCEDURE, 5 MONTHS POST THE THIRD PROCEDURE, 4 MONTHS POST THE FOURTH PROCEDURE AND 1 MONTH POST THE FIFTH PROCEDURE, THE PATIENT SUFFERED FROM RESTENOSIS OF THE CANNULATION ZONE OF THE BRACHIO-BASILIC AVF. THE PATIENT WAS TREATED WITH MEDICATION AND A PERCUTANEOUS INTERVENTION WITH DCB, PLAIN BALLOON, HIGH PRESSURE BALLOON AND CUTTING BALLOON RESULTING IN A FINAL RESIDUAL STENOSIS OF 15%. DURING THIS PERCUTANEOUS INTERVENTION 6 NON MDT BALLOONS WERE USED TO TREAT THE IN CANNULATION ZONE OF THE L

  Patient problems: Stenosis

  MAUDE report 16136164 ↗
• MalfunctionJul 15, 2020Leak/Splash

  INCIDENT DESCRIPTION: UPON DOING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ON PATIENT'S RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), THE DRUG-ELUTING BALLOON APPEARED TO BE LOSING ATMOSPHERES OF PRESSURE DUE TO POSSIBLE LEAKAGE OF BALLOON. THE DWELL TIME FOR THIS BALLOON IS 3 MINUTES AT 8 ATMS, BUT AFTER 2 MINUTES, ALL SOLUTION IN INFLATION DEVICE WAS GONE, SO WE HAD TO DISCONNECT INFLATION DEVICE, REFILL W/SALINE CONTRAST MIXTURE AND RE-INFLATE. THEN I NOTICED THE DEVICE WAS LEAKING OUT OF THE PROXIMAL END OF BALLOON CATHETER AT THE JUNCTION BETWEEN THE CLEAR Y-CONNECTOR AND THE BLUE CATHETER SHAFT ON THE PROXIMAL END. NO HARM WAS DONE TO PATIENT. NO OTHER BALLOONS OR DEVICES USED. RESULTS OF PROCEDURE WERE GOOD. PROCEDURAL NOTE: PROCEDURE IN DETAIL: WE ENGAGED THE RIGHT COMMON ILIAC ARTERY WITH A DIAGNOSTIC INTERNAL MAMMARY ARTERY (IMA) CATHETER, ADVANCED A GLIDEWIRE STIFF EXCHANGE LENGTH INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY. WE THEN EXCHANGED OUR SHORT 6-FRENCH SHEATH WITH A 6-FRENCH 45 CM COOK SHEATH. WE TRAVERSED THE LESION. WE PREDILATED THE SHEATH WITH A 5 MM BALLOON, AND BECAUSE THE LESION WAS QUITE FOCAL AND RESPONDED PRETTY NICELY TO THE BALLOON ANGIOPLASTY, WE PROCEEDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10275405 ↗
• MalfunctionJun 26, 2020Fracture; Difficult to Remove; Fracture; Difficult to Remove

  PHYSICIAN INTENDED TO USE AN INPACT ADMIRAL DRUG-COATED BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC SOFT GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION DIAMETER REPORTED AS 7MM. NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PRODUCT PACKAGING. IFU WAS FOLLOWED. THE PHYSICIAN REPORTED DIFFICULTY WITH 6 FRENCH SHEATH INSERTION. PHYSICIAN CHOSE THE NON-MEDTRONIC 6FR SHEATH FOR PROCEDURE BECAUSE OF THIS. ATHERECTOMY WAS PERFORMED INITIALLY FOLLOWED BY SUCCESSFUL USE OF THE INPACT ADMIRAL BALLOON. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE INPACT ADMIRAL, IT IS REPORTED TO HAVE BECOME STUCK IN THE SHEATH. THE SHAFT OF THE CATHETER IS REPORTED TO HAVE BROKEN DURING ATTEMPTED REMOVAL. THE PHYSICIAN THEN REMOVED THE SHEATH FROM THE PATIENT WITH THE BALLOON INSIDE, HELD PRESSURE ON THE ACCESS SITE, AND USED A FEMSTOP TO CONTINUE TO HOLD PRESSURE ON THE ACCESS SITE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10199179 ↗
• MalfunctionNov 29, 2018Leak/Splash; Leak/Splash

  THE PHYSICIAN INTENDED TO USE THE INPACT ADMIRAL. IT WAS REPORTED THE FIRST INPACT USED COULD NOT BE INFLATED DUE TO A LEAK ON THE CATHETER. THE PHYSICIAN ATTEMPTED TO USE A SECOND INPACT, BUT ENCOUNTERED THE SAME ISSUE. A THIRD INPACT WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES NOTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8114919 ↗
• MalfunctionSep 18, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL DEVICES WITH A 7F SHEATH AND 6MM SPIDER FX EMBOLIC PROTECTION DEVICE FOR TREATMENT OF A PLAQUE LESION IN THE PATIENTS MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). SLIGHT CALCIFICATION AND TORTUOSITY WERE REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED, INCLUDING DRAWING A NEGATIVE PRESSURE, WITHOUT ISSUE. AN UNKNOWN INFLATION DEVICE WAS USED. IT IS REPORTED THAT PINHOLE BALLOON BURST OCCURRED ON THE DEVICE AT AN INFLATION PRESSURE OF 10ATM ON THE FIRST INFLATION OF THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN TRIED A SECOND IN.PACT ADMIRAL DEVICE BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING PLAIN OLD BALLOON ANGIOPLASTY (POBA). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885604 ↗
• MalfunctionSep 17, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN HAD USED AN IN.PACT ADMIRAL DEVICE ON A PLAQUE LESION IN THE PATIENTS MID RIGHT SUPERFICIAL FEMORAL ARTERY BUT IT HAD BURST. THE PHYSICIAN THEN TOOK A SECOND IN.PACT ADMIRAL DEVICE WITH A 7F SHEATH AND A 6MM SPIDER FX EMBOLIC PROTECTION DEVICE FOR TREATMENT OF THE LESION. SLIGHT CALCIFICATION AND TORTUOSITY WERE REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED, INCLUDING DRAWING A NEGATIVE PRESSURE, WITHOUT ISSUE. AN UNKNOWN INFLATION DEVICE WAS USED. IT WAS REPORTED THAT PINHOLE BALLOON BURST OCCURRED ON THE DEVICE AT AN INFLATION PRESSURE OF 10ATM ON THE FIRST INFLATION OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING PLAIN OLD BALLOON ANGIOPLASTY (POBA). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881197 ↗
• MalfunctionJul 24, 2018Leak/Splash; Tear, Rip or Hole in Device Packaging; Leak/Splash

  THE PHYSICIAN INTENDED TO USE AN IN.PACT ADMRIAL DURING TREATMENT OF AN 85% STENOSED LESION IN THE PATIENT¿S RIGHT PROXIMAL TIBIAL/POPLITEAL TRUNK. SLIGHT CALCIFICATION WAS REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. DURING INFLATION OF THE DEVICE AT A PRESSURE OF 2 ATMS A SMALL HOLE AT THE PROXIMAL END OF THE CATHETER SHAFT ABOUT AN INCH FROM THE HUB. THIS RESULTED IN THE BALLOON PRESSURE CONTINUING TO DROP DURING INFLATION. NO HOLE IN BALLOON OR LEAK AT THE HUB REPORTED. THE PROCEDURE WAS COMPLETED WITH THIS BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714681 ↗
• MalfunctionNov 22, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE ONE IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON TO POST-DILATE A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE MID LEFT COMMON ILIAC ARTERY, SFA AND POPLITEAL ARTERY AREA. NEGATIVE PREP WAS PERFORMED WITH NO BUBBLES NOTED. NON-MDT SHEATHS AND GUIDEWIRES WERE USED, AND A SPIDER EMBOLIC PROTECTION DEVICE WAS USED. A NON-MDT INFLATION DEVICE WAS ALSO USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT WHEN THE PHYSICIAN GRADUALLY INFLATED THE DEVICE TO 4 ATM PRESSURE FOR THE FIRST TIME, THE BALLOON RUPTURED, AND A RAPID PRESSURE DROP WAS NOTED ON THE INFLATION DEVICE. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT, AND USED A NEW DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7051874 ↗
• MalfunctionJun 7, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ATTEMPT TO TREAT A LESION USING IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER, THE BALLOON BURST BELOW NOMINAL PRESSURE DURING INFLATION. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6618526 ↗