IN.PACT™ Admiral™ ADM06015013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169576353), received between Jul 12, 2017 and Jun 30, 2021 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2021Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE AN INPACT ADMIRAL DRUG COATED BALLOON WITH A 6FR SHEATH AND NON-MEDTRONIC INFLATION DEVICE DURING TREATMENT OF A 150MM CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 5MM. 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 WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. SALINE AND CONTRAST WERE USED FOR BALLOON INFLATION. A PINHOLE LEAK WAS NOTED ON THE BALLOON DURING FIRST INFLATION AT 4ATM. THE PHYSICIAN STATED CALCIUM BED POKED HOLE IN BALLOON AT 4ATM AND COULD NOT RETAIN INFLATION TO ALLOW DRUG TRANSFER. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091545 ↗
• MalfunctionFeb 18, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN ATTEMPTED TO USE AN INPACT ADMIRAL DRUG COATED BALLOON WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S MID AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 70% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE MAKING REMOVAL THROUGH THE SHEATH DIFFICULT. AFTER A FULL SALINE INFLATION MULTIPLE TIMES, THE DEVICE WOULD STILL NOT DEFLATE PROPERLY. NEGATIVE DEFLATION WAS APPLIED FOR 5-10 MINUTES AND THE BALLOON DEFLATED ENOUGH TO REMOVE. THE PHYSICIAN INFLATED AND DEFLATED THE BALLOON ON THE BACK TABLE AFTER REMOVAL AND FOUND THAT IT INDEED WAS NOT DEFLATING IN THE PROPER MANNER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342703 ↗
• MalfunctionNov 25, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS USING INPACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER DURING PROCEDURE TO TREAT A MILDLY CALCIFIED LESION IN THE DISTAL SFA. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT DURING BALLOON INFLATION, THE BALLOON BURST AT 10 AM. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368941 ↗
• InjuryJul 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO INPACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE LEFT PROX AND MID SFA (L-1). APPROX 11 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED LEFT SFA RESTENOSIS. THE PATIENT WAS TREATED WITH SURGICAL INTERVENTION AND PTA OF THE TARGET LESION (L-1). THE PATIENT RECOVERED. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE INDEX PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 8762606 ↗
• MalfunctionJan 24, 2019Break; Break

  THE PHYSICIAN INTENDED TO USE AN IMPACT ADMIRAL TO TREAT A FIBROUS LESION WITH 60% STENOSIS IN A MODERATELY TORTUOUS MID SUPERFICIAL FEMORAL ARTERY (SFA). NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES REPORTED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A PINHOLE BALLOON BURST OCCURRED DURING INFLATION TO 8ATM. THE BALLOON WAS RETRIEVED AND REMOVED FROM THE PATIENT. ANOTHER 6X150 IMPACT ADMIRAL WAS USED TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273769 ↗
• MalfunctionNov 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE THE INPACT ADMIRAL WITH A SPIDER FX 7.0, NON-MEDTRONIC INFLATION DEVICE AND A NON-MEDTRONIC 7F SHEATH, TO TREAT A MODERATELY CALCIFIED 140MM, 99% STENOSED FIBROUS/PLAQUE LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY OF DIAMETER 6.5MM. MODERATE TORTUOSITY ARE REPORTED. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED NO RESISTANCE WAS ENCOUNTERED ADVANCING THE ADMIRAL. DURING REMOVAL OF THE INPACT ADMIRAL THE BALLOON WAS CAUGHT INSIDE THE 7F SHEATH. THE SHEATH WAS REMOVED FROM THE PATIENT THE BALLOON REMAINED INSIDE THE SHEATH. A TRAILBLAZER WAS USED TO REMOVE THE SPIDER FX. THE PHYSICIAN REPORTED THAT HE ALWAYS USES A TRAILBLAZER TO RETRIEVE FILTERS THEREFORE NO ALLEGED COMPLAINT AGAINST THE SPIDER. ALL COMPONENTS WERE REMOVED FROM THE PATIENT. THE SHEATH WAS REPLACED WITH A 7FR SHEATH TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8089617 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETERS WERE USED TO TREAT THE RIGHT MID SFA. APPROXIMATELY ONE MONTH POST PROCEDURE, PATIENT SUFFERED SCLERODERMA INTERSTITIAL PNEUMONIA AND WAS TREATED WITH MEDICATION. PATIENT DIED THREE MONTHS LATER (NON-CARDIAC DEATH). INVESTIGATOR AND SPONSOR ASSESSED EVENT IS UNLIKELY RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Pneumonia

  MAUDE report 8068376 ↗
• MalfunctionOct 24, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN INPACT ADMIRAL WITH A 6FR SHEATH TO TREAT A MODERATELY CALCIFIED LESION WITH CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE MID SUPERFICIAL FEMORAL ARTERY(SFA). A 6MM SPIDER DEVICE WAS USED FOR EMBOLIC PROTECTION. AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO LEAKING WAS NOTED DURING PREP OF THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED BALLOON DEFLATION ISSUES AT THE LESION SITE AT A PRESSURE OF 8 ATM. THEY NOTED THAT THE DEVICE WOULD NOT CORRECTLY HOLD INFLATION. THE PHYSICIAN NOTICED CONTRAST LEAKING OUT THE BACK OF THE HUB OF THE DEVICE. ATTEMPTS TO DEFLATE THE DEVICE WERE NOT SUCCESSFUL. THE PROCEDURE WAS COMPLETED BY SLOWLY GETTING THE SEMI INFLATED BALLOON OUT OF THE SHEATH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7998962 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF MODERATELY CALCIFIED FIBROUS LESIONS WITH 80% STENOSIS IN THE DISTAL MID LEFT SUPERFICIAL FEMORAL ARTERY (ARTERY DIAMETER 6MM), PHYSICIAN FIRST PREPPED TWO LESIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE AND THEN POST DILATED WITH TWO IN.PACT ADMIRAL BALLOONS. FOLLOWING POST-DILATION, A DISSECTION WAS NOTED IN THE DISTAL SFA AND POPLITEAL ARTERY THAT WAS DETERMINED TO REQUIRE STENTING. THE PHYSICIAN THEN USED AN EVERFLEX ENTRUST WITH A NON-MEDTRONIC 7FR. 55CM SHEATH AND A SPIDER FX 7MM EMBOLIC PROTECTION DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING DEPLOYMENT. THE PHYSICIAN DECIDED TO POST DILATE THE STENT OVER A WHOLEY WIRE THAT WAS PLACED INSIDE THE STENTED SEGMENT. HE POST-DILATED THE STENT WITH A NON-MEDTRONIC 6X100 PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) BALLOON. THE PATIENT IS REPORTED TO BE DOING FINE AND THE FINAL ANGIOGRAM SHOWED A PATENT VESSEL WITH BETTER RUNOFF TO THE DISTAL VESSELS.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 7994383 ↗
• MalfunctionFeb 1, 2018Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN IMPACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON WITH A NON-MDT 6FR SHEATH, NON-MDT .035" GUIDEWIRE AND 6MM SPIDER FX EMBOLIC PROTECTION DEVICE FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). LESION EXHIBITED 85% STENOSIS. VESSEL REPORTED TO BE MODERATELY TORTUOUS. A NON-MDT INFLATION DEVICE WAS USED. IFU WAS FOLLOWED AND DEVICE PREPPED WITHOUT ISSUE. IT IS REPORTED THAT AT A PRESSURE OF 2ATM, THE BALLOON BURST DURING BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. ALL FRAGMENTS WERE RETRIEVED. ANOTHER DCB WAS OPENED TO COMPLETE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7233338 ↗
• MalfunctionJul 12, 2017Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DURING PROCEDURE FOR TREATMENT OF THE DISTAL RIGHT SFA AND POPLITEAL ARTERY. THE CALCIFIED LESION EXHIBITED LITTLE TORTUOSITY AND SEVERE CALCIFICATION WITH CHRONIC TOTAL OCCLUSION 100%. ARTERY DIAMETER WAS 6MM WITH A LESION LENGTH OF 200MM. LONG CTO USING POPLITEAL APPROACH WAS REPORTED. A NON MEDTRONIC SHEATH AND 0.018 WIRE WERE ALSO USED DURING PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. A NON MEDTRONIC INFLATION DEVICE WAS USED DURING PROCEDURE WITH CONTRAST/SALINE MIX. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT IS REPORTED THAT THE DEVICE OR COMPONENT DETACHED, CRACKED, OR FRACTURED UPON REMOVAL THROUGH THE SHEATH. THE BREAK/FRACTURE OCCURRED AT CATHETER. REMOVAL DIFFICULTIES WERE REPORTED. THERE WAS DIFFICULTY REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. PROCEDURE WAS COMPLETED USING BRACHIAL AP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6705113 ↗