In.Pact™ 018 IPU05015013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000291488), received between Feb 18, 2026 and Sep 21, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Burst Container or Vessel

  It was reported that during the procedure, during the first balloon inflation at nominal pressure, the InPact 018 drug coated balloon incurred a pinhole rupture. The pressure was slowly increased up to 6 atmospheres. Calcification and mild tortuosity were reported. A 6Fr 45cm non-Medtronic sheath and a non-Medtronic guidewire were used. Embolic protection was not used. No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray. The device was prepped as per the IFU. The balloon did not detach/fragment. The balloon did not pass through a previously deployed stent. No resistance was encountered during delivery. The procedure was completed using a non-Medtronic balloon. No patient symptoms or complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837762 ↗
• MalfunctionFeb 18, 2026Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE MID SUPERFICIAL FEMORAL ARTERY USING THE INPACT 018 DRUG COATED BALLOON, A PIN HOLE BALLOON BURST OCCURRED DURING THE FIRST INFLATION. A 6FR NON-MEDTRONIC SHEATH AND A 018 GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON DID NOT DETACH DURING THE EVENT. NO CALCIUM WAS NOTED IN THE AREA OF INFLATION. THE BALLOON WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375820 ↗

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