PACIFIC XTREME PCU050200130 (UDI 08033477058467)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477058467), received between Aug 11, 2017 and Jan 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionJan 15, 2020Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A PACIFIC XTREME PTA BALLOON DURING PROCEDURE TO TREAT A PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA).THERE WAS LITTLE DEGREE OF TORTUOSITY AND LITTLE DEGREE OF CALCIFICATION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU AND NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A PINHOLE BALLOON LEAK OCCURRED DURING BALLOON INFLATION AT NOMINAL PRESSURE. NO BALLOON FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591344 ↗
• MalfunctionAug 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PHYSICIAN USED TWO PACIFIC XTREME DEVICES TO TREAT A LESION LOCATED IN THE SFA. THE DEVICE WAS REMOVED FROM ITS PACKAGING PREPPED PER THE IFU AND INSPECTED BEFORE USE WITH NO ISSUES NOTED. EMBOLIC PROTECTION WAS NOT USED AND A NON-MDT INFLATION DEVICE WAS USED. THE BALLOONS DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT EXCESSIVE FORCE WAS NOT USED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT BOTH BALLOONS WERE TWISTED. NO REWRAP TOOL WAS USED AND NO REWRAP ISSUES WERE NOTED. THE PHYSICIAN CONTINUED WITH THE DEVICES AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787719 ↗

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)