PACIFIC XTREME PCU070250130Recalls & reported problems
Medtronic, Inc. · CATH PCU070250130 PCU US 07 00L250UL1300 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477075952), received between May 5, 2020 and May 5, 2020 — 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
Device problems
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2020Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON DURING TREATMENT OF A 300MM LESION IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. MILD VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED LESION EXHIBITED 80% STENOSIS. NO DAMAGED NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITHOUT ISSUE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE LESION WAS PRE-DILATED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED. IT IS REPORTED A BALLOON BURST OCCURRED AT INFLATION PRESSURE OF 8ATM. IT IS REPORTED A PART OF THE BALLOON REMAINED IN THE PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10023715 ↗
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 · TerminatedPacific Xtreme (PTCA Balloon Dilation Catheter)
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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