PACIFIC XTREME PCU040300130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477058429), received between Feb 6, 2019 and Feb 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 6, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A 4X300X130 PACIFIC XTREME PTA BALLOON TO TREAT A MODERATELY CALCIFIED NON TORTUOUS 200MM LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY(SFA). VESSEL DIAMETER REPORTED AS 4MM. THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 4MM <(>&<)> 200MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR SHEATH AND A 45CM NON-MEDRONIC GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE AND 50/50 CONTRAST/SALINE SOLUTION WAS USED AS INFLATION FLUID. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE PACIFIC XTREME PTA BALLOON WAS INFLATED AND RUPTURED. A 4X250X130 PACIFIC XTREME PTA BALLOON WAS USED WITHOUT INCIDENT TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310105 ↗

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)