Pacific™ Plus PCP035060130Recalls & reported problems
Medtronic, Inc. · CATH PCP035060130 PCP D3.50 L 60 UL 1300 · Class 2
All models of Pacific Plus (25)
Data updated Oct 16, 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 08033477055350), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- Embolism/Embolus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A CATHETER PACIFIC PLUS BALLOON FOR TREATMENT IN THE PEDAL ARTERY THE BALLOON BURST DURING THE PROCEDURE, AND SUBSEQUENTLY DETACHED. A PORTION OF THE DEVICE REMAINED IN THE PATIENT. DISTAL EMBOLIZATION WAS ALSO REPORTED FOR THE DETACHED PIECE OF THE BALLOON. THE DETACHED PORTION OF THE DEVICE WAS LEFT IN THE PATIENT WITHOUT INTERVENTION, AND NO INTERVENTION IS PLANNED TO REMOVE THE DETACHED PIECE OF THE BALLOON.
Patient problems: Embolism/Embolus
MAUDE report 20901578 ↗
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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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