PACIFIC XTREME PCU060250130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033477075877), received between Oct 11, 2019 and Nov 10, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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.

• MalfunctionNov 10, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FRENCH 45CM NON-MEDTRONIC SHEATH AND 6MM SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 20MM CALCIFIED LESION IN THE PATIENT'S PROXIMAL RIGHT POPLITEAL ARTERY. SEVERE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 SALINE CONTRAST MIX FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT.  A BALLOON BURST IS REPORTED AT 8ATM ON FIRST INFLATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE. A SECOND PACIFIC XTREME PTA BALLOON WAS OPENED AND PREPPED WITHOUT ISSUE. THE SECOND PACIFIC XTREME BALLOON BURST AT 8ATM ON FIRST INFLATION. NO BALLOON FRAGMENTATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE.AN ADDITIONAL BALLOON OF THE IDENTICAL SIZE WAS TAKEN FROM THE CUSTOMERS CONSIGNMENT TO COMPLETE THE ANGIOPLASTY. NO PATIENT INJURY REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786739 ↗
• MalfunctionApr 3, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 200MM CALCIFIED LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION IS REPORTED. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE IS REPORTED DURING ADVANCEMENT OF THE DEVICE. 50/50 SALINE/CONTRAST MIX WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION OF THE BALLOON. IT IS REPORTED NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT. THE PHYSICIAN THEN DECIDED TO TREAT WITH AN EVERFLEX ENTRUST SELF-EXPANDING STENT SYSTEM USING THE SAME SHEATH AND WIRE. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THE EVERFLEX ENTRUST STENT WAS UNABLE TO CROSS THE L

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9920202 ↗
• MalfunctionOct 11, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON CATHETER TO CARRY OUT A PROCEDURE ON THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LEFT MID, FIBROUS LESION WAS MODERATELY CALCIFIED AND MINIMALLY TORTUOUS. THERE WAS 100% LESION STENOSIS (CHRONIC TOTAL OCCLUSION). THE LESION LENGTH WAS 300 MM, WHERE THE ARTERY WAS 6 MM IN DIAMETER. THERE WAS "SERIOUS IN STENT RESTENOSIS" RELATED TO THE ANATOMY. THE SHEATH WAS 6F. THERE WAS NO EMBOLIC PROTECTION DEVICE USED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE IFU WAS FOLLOWED DURING PREPARATION AND PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN PASSED THE BALLOON THROUGH A PREVIOUSLY-DEPLOYED STENT AND ENCOUNTERED NO RESISTANCE. UPON THE SECOND INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE, 6 ATM. IT WAS A CIRCUMFERENTIAL / RADIAL BALLOON BURST. ALL BALLOON FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A SECOND PTA BALLOON OF THE SAME SIZE AND LOT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182223 ↗

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)