PACIFIC XTREME PCU050200130 (UDI 08033477076065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033477076065), received between Jun 4, 2020 and Mar 27, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 27, 2021Burst Container or Vessel; Leak/Splash; Material Twisted/Bent; Burst Container or Vessel; Leak/Splash; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE PACIFIC XTREME PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 50% STENOSIS. THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 170MM RESPECTIVELY. A MEDTRONIC INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS NOT PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING BALLOON INFLATION A PINHOLE LEAK WAS NOTED AT 8ATM. ALL BALLOON FRAGMENTS WERE RETRIEVED. BALLOON TWIST WAS ALSO NOTED. THE DEVICE DID NOT PASS THROUGHA PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE BALLOON WAS ADVANCED AND UPON INFLATION, UNDEPLOYED SEGMENT WAS NOTED UNDER FLUOROSCOPY. BALLOON WAS DEFLATED AND REINFLATED BUT UNDEPLOYED SEGMENT STILL VISIBLE. DURING SECOND INFLATION BALLOON BURST AT NOMINAL PRESSURE. BALLOON WAS REMOVED AND ANOTHER BALLOON WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579997 ↗
• MalfunctionOct 9, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ATTEMPT TO USE PACIFIC XTREME BALLOONS, THE TWO BALLOONS WERE BOTH INSERTED INTO THE BODY, AND WHEN INFLATED DID NOT FULLY INFLATE IN THE MIDDLE OF THE BALLOON.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10655042 ↗
• MalfunctionJun 4, 2020Leak/Splash; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA BALLOON CATHETER ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014 GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT MID SFA WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS SEVERELY TORTUOUS WITH 6MM DIAMETER. THERE WERE NO DAMAGES TO THE PACKAGINGS. THERE WERE NO ISSUES NOTED WHEN REMOVING DEVICES FROM HOOP/TRAY. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE BALLOONS WERE INFLATED USING AN INFLATION DEVICE. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITH NO RESISTANCE FELT WHEN ADVANCING THE DEVICE. DURING PACIFIC XTREME BALLOON INFLATION, PIN HOLE LEAK WAS NOTED AT 8ATM. PHYSICIAN EXCHANGED FOR A FORTREX PTA BALLOON AND DURING BALLOON INFLATION, A PIN HOLE LEAK WAS ALSO NOTED AT 8ATM. IT WAS REPORTED THAT THE FIRST BALLOON RUPTURED AT THE DISTAL END PRIOR STENT IT WAS A 5X200X130 PACIFIC XTREME .018 BALLOON. THEN A 6X40X135 FORTREX BALLOON WAS USED AND ALSO RUPTURED. THEN A 6X60X120 EVERFLEX STENT WAS PLACED AT DISTAL END OF PREVIOUSLY DEPLOYED STENT. THEN A 6X20X135 FORTREX BALLOON WAS USED TO POST DILATE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117655 ↗

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)