PACIFIC XTREME PCU040150130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477075969), received between Oct 9, 2020 and Nov 14, 2022 — 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.

• MalfunctionNov 14, 2022Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE TWO PACIFIC XTREME PTA BALLOON DILATATION CATHETER DURING TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE MID REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A NON-MDT INFLATION DEVICE WAS USED, AND CONTRAST HEP SALINE WAS USED DURING INFLATION. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLYDEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES, EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BOTH BALLOONS BURST AT 4 ATM. A NON-MEDTRONIC NEW BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789704 ↗
• MalfunctionOct 9, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ATTEMPT TO USE PACIFIC XTREME BALLOONS, THE TWO BALLOONS WERE BOTH INSERTED INTO THE BODY, AND WHEN INFLATED DID NOT FULLY INFLATE IN THE MIDDLE OF THE BALLOON.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10655051 ↗

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)