PACIFIC XTREME PCU070200130 (UDI 08033477035383)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477035383), received between Feb 14, 2017 and Feb 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Distortion” (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.

• MalfunctionFeb 14, 2017Material Distortion; Material Distortion

  PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE LEFT, DISTAL SUPERFICIAL FEMORAL ARTERY USING A PACIFIC XTREME BALLOON. TARGET LESION WAS CALCIFIED AND FIBROUS WITH LITTLE TORTUOSITY, MODERATE CALCIFICATION AND 75% STENOSIS. ARTERY DIAMETER WAS 7 MM AND LESION LENGTH WAS 300 MM. IT IS REPORTED THAT WHEN INFLATING THE BALLOON TO 4 ATM USING AN INFLATION DEVICE AND FLUID (1:1, HEP SALINE: CONTRAST) A BALLOON TWIST OCCURRED. THE BALLOON WAS USED DURING 3 SEPARATE INFLATIONS, WITH THE TWIST BEING OBSERVED IN EVERY INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6329170 ↗

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)