PACIFIC XTREME PCU070200130 (UDI 08033477075938)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033477075938), received between Aug 9, 2019 and Mar 2, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2020Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON DURING TREATMENT OF A 200MM FIBROUS LESION IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. VESSEL DIAMETER IS REPORTED 7MM. LESION EXHIBITED 80% STENOSIS. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WEN REMOVING THE DEVICE FROM THE PACKAGING. A 7FR NON-MEDTRONIC SHEATH AND NITREX WIRE WERE USED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WITH 50/50 INFLATION FLUID WAS USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT NO RESISTANCE WAS ENCOUNTERED. IT IS REPORTED WHEN INFLATING THE BALLOON AT THE LESION SITE AT A PRESSURE OF 4ATM A TWIST WAS NOTED. A REWRAP ISSUE WAS NOTED. THE BALLOON WAS REMOVED, AND A SECOND PACIFIC XTREME WAS ADVANCED THE SAME WAY. TWO TWISTS WERE OBSERVED ON THE SECOND BALLOON. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NANOCROSS BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774120 ↗
• MalfunctionMar 2, 2020Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON DURING TREATMENT OF A 200MM FIBROUS LESION IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. VESSEL DIAMETER IS REPORTED 7MM. LESION EXHIBITED 80% STENOSIS. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WEN REMOVING THE DEVICE FROM THE PACKAGING. A 7FR NON-MEDTRONIC SHEATH AND NITREX WIRE WERE USED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WITH 50/50 INFLATION FLUID WAS USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT NO RESISTANCE WAS ENCOUNTERED. IT IS REPORTED WHEN INFLATING THE BALLOON AT THE LESION SITE AT A PRESSURE OF 4ATM A TWIST WAS NOTED. A REWRAP ISSUE WAS NOTED. THE BALLOON WAS REMOVED, AND A SECOND PACIFIC XTREME WAS ADVANCED THE SAME WAY. TWO TWISTS WERE OBSERVED ON THE SECOND BALLOON. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NANOCROSS BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774115 ↗
• MalfunctionAug 9, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A PACIFIC XTREME DURING TREATMENT OF AN UNKNOWN LESION IN THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). IFU WAS FOLLOWED. DEVICE WAS PREPPED WITHOUT ISSUE. AN EVEREST INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT A BALLOON BURST OCCURRED AT 6ATM. ALL BALLOON FRAGMENTS RETRIEVED. ANOTHER PTA BALLOON OF SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8878271 ↗

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)