Pacific™ Plus PCP030150130Recalls & reported problems
Medtronic, Inc. · CATH PCP030150130 PCP D3.00 L 150 UL 130 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477055268), received between Sep 6, 2022 and Sep 6, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE PACIFIC PLUS DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED, FIBROUS LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS NONE CALCIFIED. NO EMBOLIC PROTECTION WAS USED. INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING REMOVAL AFTER INFLATION WAS COMPLETED, COMPONENT DETACHMENT OCCURRED, WITH BREAK AT THE CATHETER. THE BALLOON WAS IN THE PROXIMAL SFA FROM AN ACCESS SITE IN THE PEDAL ANATOMY. USING A SLENDER NON-MEDTRONIC SHEATH. THE PRODUCT WAS DETACHED ON THE CATHETER SHAFT MID-WAY ON THE CATHETER, BROKE OFF MIDWAY ON THE CATHETER SHAFT. THE DETACHED PORTION DID NOT REMAIN IN PATIENT. PHYSICIAN HAD ACCESS FROM THE PEDAL APPROACH WHICH IS WHERE THIS BALLOON WAS INSERTED. IN ORDER TO RETRIEVE, THE PHYSICIAN GAINED ACCESS FROM ABOVE, PLACED A SEPARATE WIRE FROM ABOVE AND BALLOONED TO CREATE A CHANNEL. ONCE INFLATIONS FROM THE BALLOON IN THE GROIN WHERE COMPLETED PHYSICIAN ABLE TO RETRIEVE THE WIRE AND
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15365778 ↗
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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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