IN.PACT™ Admiral™ ADM05025013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169975071), received between Jan 17, 2019 and Jan 19, 2026 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN PACT ADMIRAL BALLOONS WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. APPROXIMATELY 3 YEARS 5 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA. OCCLUDED MID-FEMORAL TO MID POPLITEAL STENT (LEFT LEG) TREATED WITH ATHERECTOMY, PLAIN OLD BALLOON ANGIOPLASTY, DRUG COATED BALLOON. THE EVENT WAS ALSO TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 24109193 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 IN.PACT ADMIRAL BALLOONS WERE USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. A 3RD IN.PACT ADMIRAL BALLOON WAS USED TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 4 YEARS AND 1 MONTH POST PROCEDURE PATIENT SUFFERED LEFT LOWER EXTREMITY CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL AND NON-TARGET LESION/VESSEL. OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY, POPLITEAL, PERONEAL, POSTERIOR TIBIAL AND ANTERIOR TIBIAL ARTERIES. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 22963439 ↗
• MalfunctionAug 12, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A SEVERELY CALCIFIED LESION (90% STENOSIS, 250 MM LENGTH, 5 MM DIAMETER) IN THE MID RIGHT S UPERFICIAL FEMORAL ARTERY USING THE INPACT ADMIRAL DRUG COATED BALLOON ADM05025013P 05.00 L250 UL1300 US, THERE WAS A 20-MINUTE DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. REMOVAL DIFFICULTIES OCCURRED WHEN THE BALLOON CATHETER CAUGHT UPON THE 45CM 7FR NON-MEDTRO NIC SHEATH DURING WITHDRAWAL, AND THE BALLOON TORE. THE VESSEL WAS PRE-DILATED WITH A 5X200 NON-MEDTRONIC DEVICE AND POST-DILATED WITH AN ADMIRAL 5X250 DEVICE. EMBOLIC PROTECTION WAS USED WITH A 0.014 SPIDER FX FILTER WIRE, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED 6X200 PROTEGE EVERFLEX STENT. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST. THE DEVICE WAS SAFELY REMOVED WITHOUT INTERVENTION WITH SHEATH AND WIRE ACCESS STILL IN PLACE. THE PROCEDURE WAS FINISHED AND CLOSED WITH ANGIOSEAL. THERE WAS NO VESSEL DAMAGE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783028 ↗
• InjuryApr 1, 2025Adverse 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 TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT, POPLITEAL 2 SEGMENT. APPROXIMATELY 33 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL. PATIENT WAS TREATED WITH PERCUTANEOUS INTE RVENTION. TOTALLY OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) (TARGET LESION), SUB TOTALLY OCCLUDED MID P2 SEGMENT (TARGET LESION), TOTALLY OCCLUDED ANTERIOR/POSTERIOR TIBIAL ARTERY. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 21739536 ↗
• InjuryApr 1, 2025Adverse 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 TO TREAT THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT AND POPLITEAL 2 SEGMENT. APPROXIMATELY 36 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL LIMB ISCHEMIA OF TARGET LIMB INVOLVING TARGET LESION/VESSEL AND NON-TARGET LESION/VESSEL. OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA), LEFT POPLITEAL (TARGET LESION), LEFT ANTERIOR TIBIAL AND PERONEAL ARTERIES (NON-TARGET LESIONS). PATIENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Ischemia; Obstruction/Occlusion; Stenosis

  MAUDE report 21739220 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO INPACT ADMIRAL DCBS AND AN EVERFLEX ENTRUST STENT WERE USED TO TREAT THE LEFT SUPERFICIAL FEMORAL PROXIMAL AND SUPERFICIAL FEMORAL MIDDLE VESSELS. DURING A REVASCULARIZATION PROCEDURE TWO INPACT ADMIRAL DCBS AND AN EVERFLEX ENTRUST STENT WERE USED TO TREAT THE RIGHT SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE AND SUPERFICIAL FEMORAL DISTAL VESSELS. 18 MONTHS POST INDEX PROCEDURE TWO AREAS OF IN-STENT STENOSIS WERE NOTED DURING ANGIOGRAM AND IT WAS DECIDE TO PROCEED WITH INTERVENTION. PATIENT WAS TREATED WITH INTERVENTION OF THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL VESSELS WITH TWO INPACT 018 DCB. THE PATIENT IS RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS RELATED TO DEVICE AND NOT RELATED TO THE PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 20727225 ↗
• MalfunctionApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A INPACT ADMIRAL DCB BALLOON WITH A 5 X 250MM X 130 CM INPACT ADMIRAL SHEATH AND A 035 GUIDEWIRE DURING TREATMENT OF A CALCIFIED PLAQUE LESION IN A PATIENT. 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. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT WAS REPORTED PHYSICIAN WAS DOING AN INTERVENTION AND DURING A BALLOON EXCHANGE THE INPACT ADMIRAL BALLOON BROKE INTO 2 PIECES. PHYSICIAN WAS ABLE TO REMOVE BOTH PIECES FROM THE PATIENT WITH NO HARM TO PATIENT. DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141448 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A IN.PACT ADMIRAL WAS USED TO TREAT THE SUPERFICIAL FEMORAL PROXIMAL. IMMEDIATELY POST PROCEDURE PATIENT SUFFERED VESSEL DISSECTION B IN SUPERFICIAL FEMORAL PROXIMAL LEFT. SUBINTERNAL ENTRY AND EXIT. FLOW LIMITING DISSECTION REQUIRING STENTING. NOTED AFTER SHOCKWAVE BALLOON AND DCB ANGIOPLASTY OF SUPERFICIAL FEMORAL PROXIMAL LEFT. PATIENT RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 18434030 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE COMMON FEMORAL ARTERY, THE PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND THE POPLITEAL 1 AND POPLITEAL 2 SEGMENTS. APPROXIMATELY 9 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM SEVERE LEFT LEG CLAUDICATION (LEFT COMMON FEMORAL, SFA AND POPLITEAL ARTERIES RESTENOSIS). THE EVENT WAS TREATED WITH A TARGET LESION REVASCULARIZATION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS PROBABLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Pain; Stenosis

  MAUDE report 16476451 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE RIGHT PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERY (R1). DURING THE PROCEDURE THE PATIENT SUFFERED FROM A TYPE B DISSECTION IN THE PROXIMAL AND MID SFA. IT WAS CONFIRMED THAT THE DISSECTION WAS CAUSED BY BOTH DCBS. IT WAS ALSO STATED THAT DCB LOT NUMBER 0011091247 (PLI20) ALSO HAD A GEOGRAPHIC MISS. THE EVENT WAS TREATED WITH PROVISIONAL STENTING. THE PATIENT RECOVERED. THE PROCEDURAL RESULTS SHOWED GOOD INFLOW AND OUTFLOW WITH NO PERFORATION. THE AE WAS ASSESSED AS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Vascular Dissection

  MAUDE report 15713333 ↗
• MalfunctionJun 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN USED AN INPACT ADMIRAL BALLOON TO TREAT A CTO (CHRONIC TOTAL OCCLUSION-100%) LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. MODERATE TORTUOSITY AND CALCIFICATION WAS REPORTED. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 6FR SHEATH AND 6MM SPIDER WERE USED. THE BALLOON INFLATED SUING AN INFLATION DEVICE. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. IT IS REPORTED THAT DURING REMOVAL THROUGH SHEATH A BREAK/FRACTURE OCCURRED AT THE BALLOON. ACCESS WAS OBTAINED ON LEFT SIDE TO TAKE FINAL ANGIOGRAM. THE DCB TORE DURING REMOVAL THROUGH A 6FR SHEATH. THE PHYSICIAN NOTED THAT THE SHEATH VIA ANTIGRADE ACCESS HAD A DIFFICULT ANGLE. THE DCB CATHETER WAS REMOVED WITH ONLY A PORTION OF THE DCB EXITING. THE PHYSICIAN THEN REMOVED THE SPIDER, THE DISTAL PORTION OF THE DCB AND THE SHEATH TOGETHER. THE SHEATH WAS KINKED MIDWAY THROUGH THE SHORT SHEATH. THE SHEATH USED WAS A NON-MEDTRONIC DEVICE. ALL ITEMS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565600 ↗
• MalfunctionDec 17, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN IMPACT ADMIRAL DRUG-COATED BALLOON TO TREAT A LITTLE TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID AND DISTAL SUPERFICIAL FEMORAL ARTERY. NON-MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE BALLOON. DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT BALLOON RUPTURED ON CALCIFIED PREVIOUSLY STENTED LESION. DURING BALLOON INFLATION A LONGITUDINAL BALLOON BURST OCCURRED AT 7ATM. ALL FRAGMENTS WERE RETRIEVED FROM THE BALLOON. DEVICE WAS PASSED THROUGH PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT. NO EXCESSIVE FORCE USED. NO FURTHER TREATMENT PROVIDED TO VESSEL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024731 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN. PACT ADMIRAL DRUG-COATED BALLOONS WERE USED TO TREAT THE PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL AND POPLITEAL 1 SEGMENT. DURING THE PROCEDURE, THE PATIENT SUFFERED FROM A FLOW LIMITING DISSECTION WHICH WAS NOTED AFTER THE SECOND DCB BALLOON INFLATION. THE EVENT WAS TREATED USING STENTING WITH A NON-MDT DEVICE. PATIENT RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 12622077 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL DRUG-COATED BALLOONS WERE USED TO TREAT THE PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL AND POPLITEAL 1 SEGMENT. DURING THE PROCEDURE, THE PATIENT SUFFERED FROM A FLOW LIMITING DISSECTION WHICH WAS NOTED AFTER THE SECOND DCB BALLOON INFLATION. THE EVENT WAS TREATED USING STENTING WITH A NON-MDT DEVICE. PATIENT RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 12622075 ↗
• MalfunctionAug 12, 2021Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  A PHYSICIAN WAS ATTEMPTING TO USE AN INPACT ADMIRAL DRUG-COATED BALLOON TO TREAT A SEVERELY CALCIFIED, LITTLE TORTUOUS LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION PRESENTED WITH 70% STENOSIS. A NON-MEDTRONIC EMBOLIC PROTECTION WAS USED. NO DAMAGE NOTED TO PACKAGING. NO ISSUE WHEN REMOVING THE DEVICE FROM HOOP/TRAY. PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED A BALLOON BURST OCCURRED. WHILE BALLOON WAS BEING DEFLATED IT RUPTURED. BALLOON WAS INFLATED FOR 3 MINS AND RUPTURED WHEN IT CAME DOWN. BALLOON BURST OCCURRED AT 5 ATM'S. ALL FRAGMENTS OF BALLOON WERE RETRIEVED. NO INTERVENTION WAS REQUIRED FOR REMOVAL. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING DEVICE. NO EXCESSIVE FORCE USED. BALLOON WAS USED TO COMPLETE THE PROCEDURE. ANGIO WAS PERFORMED AND NO VESSEL DAMAGE WAS NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313734 ↗
• MalfunctionJul 7, 2021Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN INPACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER ALONG WITH NON-MEDTRONIC 6FR 45CM SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 75% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 250MM RESPECTIVELY. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON DEFLATION DIFFICULTIES OCCURRED. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. 60ML SYRINGE USED TO PULL NEGATIVE AND DEFLATE THE BALLOON. DISTAL 50MM OF THE IPA DCB WOULD NOT DEFLATE, PULLED NEGATIVE TO DEFLATE AS MUCH AS POSSIBLE AND THEN REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128579 ↗
• MalfunctionMar 19, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN INPACT ADMIRAL DURING TREATMENT OF THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY OR CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS ENCOUNTERED. NO EXCESSIVE FORCE WAS USED. IT IS REPORTED A BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 11 ATM ON FIRST INFLATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9852873 ↗
• MalfunctionJan 17, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE THE INPACT ADMIRAL DEVICE TO TREAT A LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE LESION WAS DESCRIBED AS SEVERELY CALCIFIED WITH 75% STENOSIS, 300MM IN LENGTH IN AN ARTERY DIAMETER OF 5MM WITH MODERATE TORTUOSITY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUED IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HENCE, NO EXCESSIVE FORCE WAS USED. AT LESS THAN 5ATM OF PRESSURE THE BALLOON WAS REPORTED TO HAVE BURST ON ITS FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256787 ↗

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