Pacific™ Plus PCP070040130Recalls & reported problems
Medtronic, Inc. · CATH PCP070040130 PCP D7.00 L 40 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477054360), received between Feb 28, 2020 and Feb 28, 2020 — 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
- Difficult to Remove1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE PACIFIC PLUS ALONG WITH .014 GUIDE WIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID SFA WITH 70% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5-6MM AND 30MM RESPECTIVELY. THE VESSEL IS LITTLE TORTUOUS. A NON MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED WHEN ADVANCING DEVICE. IT WAS REPORTED THAT PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION. THE ENTIRE 40CM BALLOON PORTION OF THE PACIFIC DEVICE BROKE OFF INSIDE THE SFA. ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN PORTION THROUGH THE SHEATH. THIS WAS NOT SUCCESSFUL. PATIENT UNDERWENT A COMMON FEMORAL CUTDOWN AND THE BROKEN PORTION WAS REMOVED THROUGH OPEN SURGERY. THERE WAS NO FURTHER PATIENT INJURY REPORTED.
Patient problems: Injury
MAUDE report 9769464 ↗
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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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