N/A 1002Recalls & reported problems

Galemed Corporation · Bubble PAP Valve with 12.5cmH2O · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 24710810093559), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

May 30, 2019Terminated
Reports of pressure relief manifold venting gas below the standard pressure.
Z-0021-2020 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

Gas/Air Leak1

Patient problems

Low Oxygen Saturation1

Recent adverse event reports

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

MalfunctionSep 15, 2025Gas/Air Leak
PATIENT SETUP UP ON BUBBLE CPAP [CONTINUOUS POSITIVE AIRWAY PRESSURE]. THE RESPIRATORY THERAPIST WAS CALLED TO BEDSIDE TO ASSESS PATIENT DUE TO DESATURATION. WHILE ASSESSING THE PATIENT, THE RESPIRATORY THERAPIST FELT FLOW ON HER ARM COMING FROM A PLACE IT SHOULD NOT HAVE. WHEN SHE INSPECTED THE O2 TUBING THAT GOES FROM THE POP OFF VALVE TO THE FLOW METER SHE NOTICED A LEAK AND HEARD THE FLOW. PATIENT WAS SWITCHED TO ANOTHER DEVICE WITHOUT ISSUE.
Patient problems: Low Oxygen Saturation
MAUDE report 23050719 ↗

Device details

UDI-DI	`24710810093559`
Brand	N/A
Model	1002
Catalog no.	XRL0009
Company	Galemed Corporation
Product code	BYE · Attachment, Breathing, Positive End Expiratory Pressure
Class	Class 2
FDA submission	K090317
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	Mar 4, 2026

Device type (GMDN): Pressure relief valve, single-use

A non-sterile device used to regulate the maximum pressure level in a circuit or system (typically containing gas) where it is essential not to exceed a pre-set maximum pressure. Should this pressure level be exceeded, this device will automatically open and vent the excess pressure from the circuit/system ensuring that an excessive pressure level is not sustained, thereby preventing damage to the patient or a parent device. It is typically used in anaesthesia machines and ventilators forming part of the breathing/gas delivery circuit/system, but may be applied to other functions. This is a single-use device.

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All Attachment, Breathing, Positive End Expiratory Pressure devices →

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