PACIFIC XTREME PCU050250130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477035536), received between Jan 4, 2017 and Jun 23, 2017 — 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.

• MalfunctionJun 23, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING AN ATTEMPT TO TREAT A MODERATELY CALCIFIED, SLIGHTLY TORTUOUS FIBROUS LESION IN THE LEFT SFA USING PACIFIC XTREME BALLOON CATHETER, IT WAS REPORTED THAT THE BALLOON BURST AT 4 ATM DURING BALLOON INFLATION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. PROCEDURE WAS COMPLETED USING ATHERECTOMY VIA "PHEONIX" FOLLOWED BY 5 MM A NON-MEDTRONIC BALLOON. A NON-MEDTRONIC BALLOON BURST IN THE SAME ATTEMPT PRIOR TO THIS FAILURE. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THERE WAS NO INJURY TO PATIENT OR CLINICAL SEQUELAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6662700 ↗
• MalfunctionJan 4, 2017Inflation Problem; Inflation Problem

  PHYSICIAN WAS ATTEMPTING TO TREAT A MODERATELY CALCIFIED/FIBROUS LESION EXHIBITING LITTLE TORTUOSITY USING THREE PACIFIC XTREME BALLOON CATHETERS. THE LESION WAS TOTALLY OCCLUDED (CTO 100% STENOSIS) AND VESSEL WAS LITTLE TORTUOUS. IT WAS REPORTED THAT DURING BALLOON INFLATION, PHYSICIAN EXPERIENCED INFLATION DIFFICULTIES WHEN BALLOON TWIST WAS NOTED ON THE THREE DEVICES. A SMALLER MORE FOCAL BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6222026 ↗

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)