PACIFIC XTREME PCU040200130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477075983), received between Feb 17, 2021 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 18, 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 15789654 ↗
• MalfunctionFeb 17, 2021Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON DURING TREATMENT OF THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BALLOON TWIST IS REPORTED. A REWRAP ISSUE WAS NOT NOTED. IT IS REPORTED THE SAME BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337551 ↗

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)