PACIFIC XTREME PCU050300130 (UDI 08033477058504)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033477058504), received between Jul 14, 2017 and Feb 6, 2018 — classified as 3 malfunctions.

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

• MalfunctionFeb 6, 2018Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  THE PHYSICIAN INTENDED TO USE THE PACIFIC XTREME PTA BALLOON AS PER IFU TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. ARTERY DIAMETER WAS REPORTED AS 5MM, AND LESION LENGTH AS 300MM. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC DEVICE, 50/50 INFLATION FLUID WAS USED. IT WAS REPORTED THAT BALLOON TWIST OCCURRED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246030 ↗
• MalfunctionJul 14, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PATIENT HAS A HISTORY OF PAD, HYPERTENSION, COPD AND CORONARY DIAGNOSTICS. THE PHYSICIAN USED 2 PACIFIC XTREME BALLOONS TO TREAT A CTO IN THE SUPERFICIAL FEMORAL ARTERY AS PER IFU. IT WAS REPORTED BOTH DEVICES WERE PREPPED AND LOADED WITH NO DIFFICULTY REPORTED. THE DEVICES WERE PASSED THROUGH PREVIOUSLY DEPLOYED STENTS WITH NO RESISTANCE. DURING THE FIRST INFLATION BOTH BALLOONS RUPTURED WHILE DILATING A GRAFT POST LASER ATHERECTOMY, A PIN HOLE LEAK WAS NOTED AT 6ATMS. BOTH DEVICES WERE REMOVED FROM THE PATIENT WITH NO ISSUES NOTED. ANOTHER DEVICE WAS USED TO TREAT AND COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6713350 ↗
• MalfunctionJul 14, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PATIENT HAS A HISTORY OF PAD, HYPERTENSION, COPD AND CORONARY DIAGNOSTICS. THE PHYSICIAN USED 2 PACIFIC XTREME BALLOONS TO TREAT A CTO IN THE SUPERFICIAL FEMORAL ARTERY AS PER IFU. IT WAS REPORTED BOTH DEVICES WERE PREPPED AND LOADED WITH NO DIFFICULTY REPORTED. THE DEVICES WERE PASSED THROUGH PREVIOUSLY DEPLOYED STENTS WITH NO RESISTANCE. DURING THE FIRST INFLATION BOTH BALLOONS RUPTURED WHILE DILATING A GRAFT POST LASER ATHERECTOMY, A PIN HOLE LEAK WAS NOTED AT 6ATMS. BOTH DEVICES WERE REMOVED FROM THE PATIENT WITH NO ISSUES NOTED. ANOTHER DEVICE WAS USED TO TREAT AND COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6713349 ↗

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)