In.Pact™ 018 IPU06012013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000291631), received between Mar 25, 2023 and Jul 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  A PHYSICIAN WAS ATTEMPTING TO USE AN IN.PACT 018 DRUG COATED BALLOON. IT WAS REPORTED THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY. WHEN THE DEVICE WAS RETURNED FOR ANALYSIS, IT WAS NOTED THAT THERE WAS A PIN HOLE IN THE BALLOON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792110 ↗
• MalfunctionMay 19, 2023Burst Container or Vessel; Burst Container or Vessel

  AN IN.PACT 018 DRUG COATED BALLOON (DCB) WAS BEING USED FOR THE TREATMENT OF A 100MM CALCIFIED LESION WITH 80% STENOSIS IN THE MID RIGHT REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER WAS 6MM AND IT WAS MODERATELY CALCIFIED. A 7MM SPIDER WAS USED FOR EMBOLIC PROTECTION. A NON MEDTRONIC INFLATION DEVICE WAS USED. THE IN.PACT DCB WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AFTER CROSSING MID SFA LESION THE PHYSICIAN WAS ABLE TO PLACE A 7MM SPIDER EPD AND MAKE 4 SUCCESSFUL PASSES WITH THE H1-M DEVICE.  THE PHYSICIAN LOADED THE .018 DCB OVER THE SPIDER WIRE. DURING THE FIRST INFLATION, THE PHYSICIAN NOTED LOSS OF PRESSURE ON THE INFLATION DEVICE AS WELL AS THE LOSS OF CONTRAST VISUAL ON FLOURO. IT WAS REPORTED DURING THE FIRST INFLATION AT 4MM THE BALLOON RUPTURED LONGITUDINALLY. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO ISSUES WERE NOTED DURING ADVANCEMENT AND NO EXCESSIVE FORCE WAS USED. THE BALLOON WAS REPLACED WITH A NON-MEDTRONIC PTA BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961154 ↗
• MalfunctionMar 25, 2023Burst Container or Vessel; Burst Container or Vessel

  AN IN PACT 018 DCB BALLOON WAS INTENDED TO BE USED FOR THE TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE DEGREE OF TORTUOSITY WAS MODERATE AND CALCIFICATION WAS SEVERE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AN UNKNOWN INFLATION DEVICE WAS USED WITH A 80/20 MIX OF SALINE/CONTRAST INFLATION FLUID. IT WAS REPORTED THE BALLOON BURST AT 8ATM DURING THE FIRST BALLOON INFLATION. ALL BALLOON FRAGMENTS WERE RETRIEVED, THE TYPE OF BURST CANNOT BE CONFIRMED. THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. AN EVERCROSS WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616651 ↗

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