PACIFIC XTREME PCU070200130 (UDI 08033477058320)Recalls & reported problems
Medtronic, Inc. · CATH PCU070200130 PCU US 07 00L200UL1300 · Class 2
All models of PACIFIC XTREME (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477058320), received between Dec 18, 2017 and Dec 18, 2017 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2017Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN EMPLOYED THE USE OF A PACIFIC XTREME PTA BALLOON CATHETER WITH A NON-MDT INFLATION DEVICE FOR THE TREATMENT OF A 100% STENOSED FIBROUS/PLAQUE LESION IN THE MID-PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). LESION WAS SLIGHTLY CALCIFIED. VESSEL SLIGHTLY TORTUOUS. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 8-9ATMS. ONE INFLATION WAS APPLIED TO THE BALLOON PREVIOUS TO BURST. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT, BUT NO RESISTANCE WAS ENCOUNTERED / NO EXCESSIVE FORCE REQUIRED. A PART OF THE BALLOON RUPTURED OFF THE CATHETER AND BECAME LODGED WITHIN THE MID-SFA. A 10MM SNARE DEVICE WAS USED TO RETRIEVE THE RUPTURED BALLOON (ALL FRAGMENTS RETRIEVED). NO PATIENT INJURY WAS REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7127035 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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