In.Pact™ 018 IPU06010013PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000291600), received between Jun 30, 2023 and Jun 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJun 30, 2023Inflation Problem; Leak/Splash; Detachment of Device or Device Component; Inflation Problem; Leak/Splash; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE AN INPACT 018 DRUG COATED BALLOON DURING TREATMENT OF A CALCIFIED PLAQUE LESION IN THE PATIENTS LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 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. IFU WAS FOLLOWED AND DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED BALLOON INFLATION DIFFICULTIES OCCURRED WHEN DEVICE WAS INFLATED TO 6ATMS. PHYSICIAN SUSPECTED LEAK. THE BALLOON WOULD NOT INFLATE, LEAK WASN¿T LOCATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETUNED FOR EVALUATION, IT WAS NOTED THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238285 ↗

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