PACIFIC XTREME PCU050150130 (UDI 08033477035499)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477035499), received between Mar 8, 2019 and Mar 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO US A PACIFIC XTREME DEVICE TO TREAT A CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO ISSUES REPORTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED ISSUES DURING PREP AND WAS NOT ABLE TO FLUSH THE BALLOON CATHETER AS THE CATHETER/DELIVERY SYSTEM WAS DEFORMED AND A KINK WAS OBSERVED. THIS DEVICE WAS NOT USED IN THE PATIENT. THE PHYSICIAN INTENDED TO US A PACIFIC PLUS, NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO ISSUES REPORTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND THAT THE DEVICE WAS UNABLE TO CROSS. A NON-MEDTRONIC CORDIS 0.35 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN WAS INTENDING TO USE AN INPACT ADMIRAL. THERE WAS NO DAMAGE NOTED TO THE DEV ICE PACKAGING AND NO ISSUES REPORTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8403496 ↗

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)