Ventlab FH603021Recalls & reported problems

Ventlab, LLC · HME w/Port Small Straight · 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 10889483110331), received between Jun 2, 2026 and Jun 2, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Fragmentation1
Obstruction of Flow1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJun 2, 2026Material Fragmentation; Obstruction of Flow
IT WAS REPORTED THAT A RESPIRATORY THERAPIST (RT) WAS ALERTED BY ACTIVATION OF THE VENTILATOR AND CENTRAL ALARM. UPON TROUBLESHOOTING, A BLUE SPONGE FROM THE HUMIDITY AND MOISTURE EXCHANGE (HME) WAS OBSERVED FLOATING WITHIN THE CORRUGATED TUBING. THE HME WAS REPLACED. NO INFORMATION REGARDING PATIENT OUTCOME WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363142 ↗

Device details

UDI-DI	`10889483110331`
Brand	Ventlab
Model	FH603021
Company	Ventlab, LLC
Product code	CAH · Filter, bacterial, breathing-circuit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 25, 2023

Device type (GMDN): Microbial medical gas filter, single-use

A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

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