PACIFIC XTREME PCU070150130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477075914), received between Apr 20, 2020 and Apr 20, 2020 — 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.

• MalfunctionApr 20, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN A MID VESSEL. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 150MM RESPECTIVELY. THERE WAS NO DAMAGE TO PACKAGING. NO ISSUES NOTED WHILE REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. THE BALLOON RUPTURED AT 6 AM DURING FIRST INFLATION. THE VESSEL WAS PRE DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLON RUPTURED AT 6ATM. THE BALLOON WAS BEING USED TO POST DILATE A STENT WHEN IT RUPTURED. THE DEVICE WAS REMOVED INTACT WITH NO HARM TO THE PATIENT. A SUBSEQUENT 7X150X130 PACIFIC XTREME PTA WAS USED WITH ISSUES TO ADEQUATELY POST DILATE THE STENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS ACHIEVING AN EXCELLENT RESULT WITH NO HARM TO THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977385 ↗

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)