BALLARD* 1000 Heat and Moisture Exchange Filter 93821Recalls & reported problems

Avanos Medical, Inc. · 1000 Heat and Moisture Exchange Filter · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00609038938219), received between Dec 3, 2020 and Dec 4, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Detachment of Device or Device Component3

Patient problems

No Consequences Or Impact To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
CORRECTION: ONLY ONE PATIENT WAS INVOLVED IN ALL THREE REPORTED EVENTS. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2021, THE PATIENT WAS BETWEEN 40-50 YEARS OLD. THE HEAT AND MOISTURE EXCHANGE (HME) WAS PLACED INLINE WITH THE VENTILATOR CIRCUIT. ONE SIDE WAS CONNECTED TO THE CIRCUIT AND THE OTHER SIDE WAS CONNECTED TO CORRUGATED TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10944297 ↗
MalfunctionDec 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
CORRECTION: ONLY ONE PATIENT WAS INVOLVED IN ALL THREE REPORTED EVENTS. PER ADDITIONAL INFORMATION RECEIVED 3 FEB 2021, THE PATIENT WAS BETWEEN 40-50 YEARS OLD. THE HEAT AND MOISTURE EXCHANGE (HME) WAS PLACED INLINE WITH THE VENTILATOR CIRCUIT. ONE SIDE WAS CONNECTED TO THE CIRCUIT AND THE OTHER SIDE WAS CONNECTED TO CORRUGATED TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10941265 ↗
MalfunctionDec 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
CORRECTION: ONLY ONE PATIENT WAS INVOLVED IN ALL THREE REPORTED EVENTS. PER ADDITIONAL INFORMATION RECEIVED 3 FEB 2021, THE PATIENT WAS BETWEEN 40-50 YEARS OLD. THE HEAT AND MOISTURE EXCHANGE (HME) WAS PLACED INLINE WITH THE VENTILATOR CIRCUIT. ONE SIDE WAS CONNECTED TO THE CIRCUIT AND THE OTHER SIDE WAS CONNECTED TO CORRUGATED TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10941232 ↗

Device details

UDI-DI	`00609038938219`
Brand	BALLARD* 1000 Heat and Moisture Exchange Filter
Model	93821
Catalog no.	157
Company	Avanos Medical, Inc.
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	Jun 21, 2023

Device type (GMDN): Heat/moisture exchanger, single-use

A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

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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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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