IN.PACT™ Admiral™ ADM05012013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169383630), received between Apr 13, 2017 and Jan 21, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• InjuryJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN IN.PACT ADMIRAL, THE TIP OF THE DRUG COATED BALLOON BROKE OFF IN THE PERIPHERAL ARTERY, SPECIFICALLY THE POPLITEAL ARTERY. THIS INCIDENT LED TO DELAYS IN SURGERY. THE BALLOON TIP WAS SUCCESSFULLY RETRIEVED USING A SNARE. THE PROCEDURE INVOLVED THE USE OF A 6FR. NON MEDTRONIC SHEATH, AND THE VESSEL WAS PRE-DILATED WITH 50/50 CONTRAST AS THE INFLATION FLUID. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21197368 ↗
• MalfunctionJul 23, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS USING AN IMPACT ADMIRAL PACLITAXEL ELUTING PTA BALLOON DURING PROCEDURE. A 50/50 CONTRAST TO HEPARINIZED SALINE WAS USED DURING PROCEDURE. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING BALLOON INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED. ALL FRAGMENTS OF THE BALLOON WAS RETRIEVED FROM PATIENT. IT WAS REPORTED THAT THE DEFECTIVE BALLOON WAS REMOVED FROM THE PATIENT INTACT AND WITHOUT PATIENT COMPLICATIONS. A NEW 6X120X130 IMPACT ADMIRAL DRUG COATED BALLOON WAS INSERTED AND INFLATED. ONCE REMOVED FINAL IMAGES WERE TAKEN OF THE LESION SITE AND NO ABNORMALITIES WERE NOTED. THE VESSEL WAS PATENT AND THE PATIENT WAS WITHOUT COMPLICATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314335 ↗
• InjuryNov 20, 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, THE PATIENT SUFFERED RIGHT SFA CTO (ACUTE OCCLUSION). REVASCULARIZATION OF THE TARGET LESION WAS CARRIED OUT 11 DAYS LATER USING A PTA BALLOON CATHETER. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS UNLIKELY RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Occlusion; Thrombus

  MAUDE report 8089386 ↗
• MalfunctionNov 13, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN INPACT ADMIRAL BALLOON CATHETER HOWEVER THE BALLOON BURST OR LEAKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063481 ↗
• MalfunctionMay 21, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN IN.PACT ADMIRAL WITH A NON-MDT 6F SHEATH FOR THE TREATMENT OF A LESION TYPE IN THE PATIENTS MID SUPERFICIAL FEMORAL ARTERY(SFA). NO CALCIFICATION WAS PRESENT. PURGING WAS NOT CARRIED OUT BEFORE THE PROCEDURE. CONTRAST AND SALINE WERE USED FOR INFLATION OF THE BALLOON. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO A PRESSURE OF 8ATMS. IT WAS DISCOVERED THAT THE BALLOON HAD A SLOW LEAK AND WOULD NOT REMAIN INFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7530221 ↗
• MalfunctionDec 18, 2017Burst Container or Vessel; Burst Container or Vessel

  AN IMPACT ADMIRAL DRUG-ELUTING BALLOON PTA CATHETER, FOR A LOWER LEFT ANGIOPLASTY PROCEDURE, BALLOON BURST OCCURRED AT NOMINAL PRESSURE (8ATM). PHYSICIAN REMOVED THE BALLOON CATHETER FROM THE PATIENT WITH NO ADVERSE EFFECTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127846 ↗
• MalfunctionNov 22, 2017Material Rupture

  WHILE USING "IN.PACT" DRUG ELUTING BALLOON (SIZE 5 X 100) AT NOMINAL PRESSURE, WHICH IS 8 ATMOSPHERES, THE BALLOON RUPTURED, AT WHICH TIME THE BALLOON CATHETER WAS REMOVED FROM PATIENT WITH NO ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053136 ↗
• 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, DIARRHOEA OR CONSTIPATION. PATIENT PRESENTED TO ER WITH A RED AND SWELLED 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 OCCLU

  Patient problems: Reaction

  MAUDE report 6629550 ↗
• 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)64) 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, DIARRHOEA OR CONSTIPATION. PATIENT PRESENTED TO ER WITH A RED AND SWELLED 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 OCCLU

  Patient problems: Reaction

  MAUDE report 6629541 ↗
• 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 6489261 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL ILIAC STENTS. THREE 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 6489251 ↗

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