In.Pact™ 018 IPU06015013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000291662), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJun 13, 2025Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO TREAT ILIAC ARTERY DISEASE UTILIZING THE DRUG COATED BALLOON 018 IPU06015013P D6.0 L150 UL0130 AND THE EVERFLEX ENTRUST 6X150X120 STENT. DURING THE PROCEDURE, MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES THROUGH THE SEVERELY CALCIFIED AND TORTUOUS RIGHT AND LEFT COMMON ILIAC ARTERIES. EXCESSIVE FORCE WAS USED DURING ADVANCEMENT OF THE DRUG-COATED BALLOON. A 7FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. A NON-MEDTRONIC INTRAVASCULAR LITHOTRIPSY CATHETER WAS USED FOR VESSEL PRE-DILATION. AN INFLATION DEVICE AND 50/50 CONTRAST INFLATION FLUID WERE USED FOR BALLOON INFLATION. THE DRUG-COATED BALLOON EXPERIENCED DEFLATION DIFFICULTIES DUE TO THE AMOUNT OF CALCIUM PRESENT, RESULTING IN THE BALLOON NOT FULLY DEFLATING AND BECOMING STUCK WITHIN THE VESSEL. NEGATIVE PRESSURE WAS APPLIED IN AN ATTEMPT TO DEFLATE THE BALLOON, BUT IT REMAINED INCOMPLETELY DEFLATED. THE BALLOON SUBSEQUENTLY DETACHED IN THE VESSEL AND WAS REMOVED USING A SNARE. THE EVERFLEX ENT RUST STENT EXPERIENCED A THUMBWHEEL MALFUNCTION, LEADING TO PARTIAL DEPLOYMENT AND THE CATHETER HANDLE WAS DELIBERATELY CRACKED TO AID STENT DE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 22201807 ↗

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