PACIFIC XTREME PCU050150130 (UDI 08033477076041)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477076041), received between Mar 21, 2022 and Jul 3, 2023 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME DURING TREATMENT OF A 150MM CALCIFIED PLAQUE LESION WITH 90% STENOSIS OF THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A 6FR NON MEDTRONIC SHEATH AND NON MEDTRONIC GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED WITH 50/50 CONTRAST. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. IT WAS REPORTED BALLOON INFLATION DIFFICULTIES WERE ENCOUNTERED AND AT NOMINAL BALLOON PRESSURE (NBP) BALLOON TWIST WAS OBSERVED. A REWRAP TOOL WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH NO ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245832 ↗
• MalfunctionMar 21, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE AND PACIFIC XTREME PTA BALLOON CATHETERS DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL POPLITEAL ARTERY (POP). THE VESSEL WAS A LITTLE TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATIOON. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 8ATM. ALL FRAGMENTS OF THE NANOCROSS BALLOON WERE RETRIEVED. PHYSICIAN REPLACED WITH A PACIFIC XTREME AND SAME THING OCCURRED. BALLOON RUPTURE OCCURRED AT 8ATM. ALL FRAGMENTS OF THE PACIFIC XTREME BALLOON WERE ALSO RETRIEVED. PROCEDURE WAS COMPLETED AFTER SECOND BALLOON RUPTURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838706 ↗

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)