Pacific™ Plus PCP025080150Recalls & reported problems
Medtronic, Inc. · CATH PCP025080150 PCP D2.50 L 080 UL 150 · 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 08033477071657), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
- Inflation Problem1
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.
MalfunctionOct 15, 2020Inflation Problem; Device Difficult to Setup or Prepare; Inflation Problem; Device Difficult to Setup or Prepare
PHYSICIAN INTENDED TO USE A PACIFIC PLUS PTA BALLOON WITH A NON-MEDTRONIC 0.018 GUIDEWIRE DURING TREATMENT OF A PLAQUE LESION IN TH E PATIENT¿S PROXIMAL POSTERIOR TIBIAL ARTERY. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 80% STENOSIS. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE IT IS REPORTED WIRE MOVEMENT ISSUES OCCURRED. THE PHYSICIAN REPORTS DIFFICULTY WHEN TRYING TO LOAD OR EXCHANGE THE GUIDEWIRE DUE TO RESISTANCE. THE WIRE WAS EVENTUALLY ABLE TO BE PASSED THROUGH THE BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. BALLOON INFLATION DIFFICULTIES ARE ALSO REPORTED. IT IS REPORTED AFTER PASSING THE WIRE THROUGH THE BALLOON WAS UNABLE TO BE INFLATED. THERE WAS NO DIFFICULTY REMOVING THE BALLOON FROM THE PATIENT AND NO INTERVENTION WAS REQUIRED. THE BALLOON WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10682286 ↗
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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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