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PleuraFlow® System with FlowGlide PFFG-24Recalls & reported problems

Clearflow, Inc. · PFFG-24 PleuraFlow® System with FlowGlide™ · Class 2

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 00856449006062), received between Jun 18, 2020 and Jun 18, 2020 — classified as 1 injury.

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

  • No Apparent Adverse Event1

Patient problems

  • Bradycardia1
  • 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.

  • InjuryJun 18, 2020No Apparent Adverse Event; No Apparent Adverse Event

    A DAY AFTER CABGX2 PROCEDURE, THE PATIENT WAS TAKEN BACK TO REPAIR A TORN VEIN GRAFT. THE CUSTOMER REPORTED THAT A CLIP ON THE PATIENT'S GRAFT MAY HAVE BEEN ATTACHED TO THE BLOOD CLOT REMOVED. THE PFFG WAS PLACED IN ANTERIOR MEDIASTINUM. THERE IS NO INFORMATION AVAILABLE IF THERE WAS A CLIP USED AT THE SITE, ACCORDING TO THE CUSTOMER.. NO CLIP WAS FOUND IN THE CF DEVICE OR DRAINAGE CANISTER ACCORDING TO THE HOSPITAL. THERE WAS NO SERIOUS INJURY. THE PATIENT'S GRAFT WAS SUTURED AND ANOTHER PFFG WAS USED . THE PATIENT HAS RECOVERED.

    Patient problems: Bradycardia; Hemorrhage/Blood Loss/Bleeding

    MAUDE report 10171460 ↗

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