Pacific™ Plus PCP020150150Recalls & reported problems
Medtronic, Inc. · CATH PCP020150150 PCP D2.00 L 150 UL 150 · Class 2
- 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 08033477071831), received between Dec 3, 2018 and Dec 3, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device1
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.
MalfunctionDec 3, 2018Device Damaged by Another Device; Device Damaged by Another Device
PHYSICIAN USED A PACIFIC PLUS BALLOON WITH A NON-MEDTRONIC INFLATION DEVICE DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENTS DISTAL LEFT ANTERIOR TIBIAL ARTERY. OTHER MEDTRONIC BALLOONS AMPHIRION DEEP AND PACIFIC PLUS WERE USED FOR PREDILATION WITH NO ALLEGED ISSUES REPORTED. MODERATE TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. DEVICE NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT THE WIRE WAS INSIDE THE BALLOON. BOTH BALLOON AND WIRE WERE REMOVED IN TANDEM. THE PROCEDURE WAS COMPLETED AT THIS POINT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8123750 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.