PACIFIC XTREME PCU040250130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477058405), received between Mar 5, 2019 and Mar 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 other recall cover devices cleared under the same FDA submission (K103464); 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 16, 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.

• InjuryMar 5, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME BALLOON TO TREAT A LESION IN A PATIENT. A NON MEDTRONIC GUIDEWIRE (VIPER) AND INFLATION DEVICE (MERRIT) WAS USED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON ADVANCED TOO FAR INTO A COLLATERAL AND DOUBLED UP ON ITSELF. THEY COULD NOT GET IT TO UN DOUBLE AND GOT STUCK IN THE ILIAC. A SNARE RETRIEVER WAS USED. NO FURTHER PATIENT INJURY REPORTED, AND PATIENT OUTCOME WAS REPORTED TO BE GOOD.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8389485 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103464. One submission often covers many models, so check the product and lot details in each record.

• Z-3055-2020 · Aug 26, 2020 · Terminated
  Pacific Xtreme (PTCA Balloon Dilation Catheter)