Pacific™ Plus PCP030040130Recalls & reported problems
Medtronic, Inc. · CATH PCP030040130 PLUS US 03L40UL1300 · 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 08033477080024), received between Jul 24, 2019 and Jul 24, 2019 — 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.
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.
MalfunctionJul 24, 2019Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PACIFIC PLUS PTA BALLOON TO TREAT A SLIGHTLY CALCIFIED, NON TORTUOUS LESION IN A DISTAL ARTERY. THE ARTERY DIAMETER WAS REPORTED AS 3MM. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. IT WAS REPORTED THAT DURING INFLATION, THE DEVICE BURST. ALL FRAGMENTS OF THE BALLOON WERE REPORTED TO HAVE BEEN RETRIEVED. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8822058 ↗
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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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