PACIFIC XTREME PCU060150130 (UDI 08033477058221)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477058221), received between May 28, 2019 and May 28, 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. 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.

• MalfunctionMay 28, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON TO TREAT A MODERATELY CALCIFIED, NON TORTUOUS, 75% STENOTIC LESION IN THE MID SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 6MM <(>&<)> 1200MM, 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 NON-MEDTRONIC SHEATH AND A NITREX 0.014 GUIDEIWRE 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 RUPTURED POST FIRST INFLATION TO 6ATM. THE BALLOON WAS REMOVED INTACT AND WITHOUT LEAVING ANYTHING IN THE PATIENT VASCULATURE. ANOTHER PACIFIC XTREME PTA BALLOON OF THE SAME SIZE WAS USED WITHOUT ANY COMPLICATIONS TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646149 ↗

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)