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Pleuraflow® System with FlowGlide PFFG3-28Recalls & reported problems

Clearflow, Inc. · PFFG3-28 Pleuraflow® System with FlowGlide · 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 00856449006192), received between May 19, 2023 and May 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Use of Device Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 19, 2023Use of Device Problem; Use of Device Problem

    THE PATIENT PRESENTED FOR SURGERY ON APRIL 20TH AND HAD A CABG X 2/AVR. THE SURGEON PLACED TWO MEDIASTINAL CHEST TUBES (1) PFFG3-28 AND (1) 24FR CHEST TUBE FROM ANOTHER MANUFACTURER (NOT IDENTIFIED). THESE TWO CHEST TUBES WERE PLACED ANTERIORLY IN THE MEDIASTINUM. A THIRD CHEST TUBE, PFFG3-28 RA, WAS PLACED IN THE LEFT PLEURAL SPACE. UPON ATTEMPTING THE FIRST ACTUATION OF THE MEDIASTINAL CHEST TUBE (PFFG3-28), THE SHUTTLE GUIDE AND CLEARANCE WIRE DECOUPLED IMMEDIATELY. THE DECISION WAS TO CLOSE THE STERNUM AND LEAVE IT IN THIS POSITION AND INFORM THE CVICU TEAM TO NOT TRY AND WITHDRAW THE SHUTTLE AND CLEARANCE WIRE PER THE IFU. UPON LANDING IN THE CVICU, THE PATIENT WAS BLEEDING HEAVILY AND AFTER ONE (1) LITER OF DRAINAGE OUTPUT IN THE FIRST HOUR, THE DECISION WAS MADE TO RETURN THE PATIENT TO THE OR FOR RE-EXPLORATION. THE PATIENT'S CHEST WAS OPENED, AND THEY DISCOVERED A DEHISCENCE OF THE DISTAL ANASTOMOSIS OF THE LIMA-LAD GRAFT THAT WAS THE CAUSE FOR THE BLEEDING. THE SURGEON RE-ANASTOMOSED, ACHIEVED HEMOSTASIS, AND CLOSED THE CHEST. IT WAS REPORTED BY THE SURGEON THAT DURING THE RE-EXPLORATION THE MAGNETIC SHUTTLE GUIDE AND CLEARANCE WIRE WERE NOT WORKING (DECOUPLING), SO HE RE

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 16966906 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.