PleuraFlow® System with FlowGlide PFFG-32Recalls & reported problems

Clearflow, Inc. · PFFG-32 PleuraFlow® System with FlowGlide™ · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00856449006086), received between Jun 6, 2017 and Jun 6, 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.

MalfunctionJun 6, 2017Detachment Of Device Component; Detachment Of Device Component
DEVICE FUNCTIONED AS INTENDED DURING THE FIRST ONE HOUR IN THE OPERATING ROOM. UPON INITIAL USE IN THE ICU, THE CHEST BARB, A COMPONENT OF THE CLEARANCE APPARATUS, SEPARATED FROM THE GUIDE TUBE COMPONENT OF THE CLEARANCE APPARATUS. THE CHEST TUBE WAS LEFT IN THE PATIENT'S CHEST AND CLAMPED IMMEDIATELY. A NEW STERILE PACKAGE WAS OPENED IN THE ICU AND A NEW CLEARANCE APPARATUS WAS CONNECTED TO THE CHEST TUBE. THE DEVICE WAS USED WITH NO FURTHER PROBLEMS UNTIL ITS REMOVAL AT END OF NORMAL USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6616895 ↗

Device details

UDI-DI	`00856449006086`
Brand	PleuraFlow® System with FlowGlide
Model	PFFG-32
Company	Clearflow, Inc.
Product code	OTK · Wound Drain Catheter System
Class	Class 2
FDA submission	K163139
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jan 3, 2024

Device type (GMDN): Closed-wound drain, non-bioabsorbable

A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Other Wound Drain Catheter System devices

Pleuraflow® System with FlowGlide PFFG3-28
Clearflow, Inc. · Wound Drain Catheter System
1 report
PleuraFlow® System with FlowGlide PFFG-24
Clearflow, Inc. · Wound Drain Catheter System
1 report
PleuraFlow® System PF-32
Clearflow, Inc. · Wound Drain Catheter System
1 report

All Wound Drain Catheter System devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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