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PleuraFlow® System PF-32Recalls & reported problems

Clearflow, Inc. · PF-32 PleuraFlow® System · 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 00856449006031), received between Sep 22, 2017 and Sep 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionSep 22, 2017Detachment Of Device Component; Detachment Of Device Component

    CLEARANCE LOOP SEPARATED FROM CLEARANCE WIRE DURING USE

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6888974 ↗

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