PACIFIC XTREME PCU060200130 (UDI 08033477035307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477035307), received between Jun 14, 2017 and Jun 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 14, 2017Defective Device; Defective Device

  A PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS FIBROUS LESION IN THE SFA WITH 90% STENOSIS. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON THE CENTER OF THE BALLOON WOULD NOT INFLATE, A BALLOON TWIST OCCURRED, THE BALLOON WOULD NOT UNWRAP. THE TWIST OCCURRED DURING INFLATION AT 12 ATM. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6639448 ↗

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)