This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. This recall was classified on October 1, 2025.
Affected Product
| Product Name | Model Number | Unique Device Identifier |
|---|---|---|
| Atlan A350 | 8621500 | 04048675556176 |
| Atlan A350 XL | 8621600 | 04048675556183 |
What to Do
Inspect and, if necessary, replace the ventilator motor assembly in all affected devices.
On September 9, 2025, Draeger, Inc. sent an Urgent Medical Device Correction to customers with instructions on how to correct the device if an error occurs:
- If the error occurs before use, e.g. in standby or system test mode, mechanical ventilation cannot be started.
- If the error occurs during a procedure, the mechanical ventilation may fail, and the device alerts the user by displaying the "Ventilator failure!!!" message. Manual ventilation or spontaneous breathing remains possible in both cases. It may be necessary to manually ventilate the patient to prevent patient injury. With the ongoing alarm of the ventilation failure, the Atlan continues to provide the Man/Spont ventilation mode, fresh-gas and agent delivery as well as all monitoring functions without restriction.
- The corrective action is to inspect, and, if necessary, replace the ventilator motor assembly. You will be contacted by your local Draeger Service Representative to arrange a date for the ventilator motor assembly inspection and, if necessary, replacement.
- Until the corrective action is implemented, you may continue operating your devices with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use.
- If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient manually as needed. Monitor the patient’s condition; specifically, their oxygenation status as a brief cessation of ventilation can potentially lead to e.g., hypoxia, loss of lung recruitment, bradycardia and cardiac arrest.
- If preferred, the alarm priority of the "Ventilator error!!!" can be downgraded with "ALARM RESET" after switching to Man/Spont ventilation mode.
- Please ensure that all users of the Draeger Atlan as well as other persons concerned within your organization are made aware of this Urgent Medical Device Correction notice. Please complete and return the attached Medical Device Correction Return Response Acknowledgment and Receipt Form to confirm that you have received this information. If you have made the products available to third parties, please forward this Urgent Medical Device Correction notice to them.
- Please retain this Urgent Medical Device Correction notice at least until your ventilator motor is inspected/replaced.
Reason for Correction
Draeger has received reports of the Atlan anesthesia workstation indicating a failure of the piston ventilator before use, and failures of the mechanical ventilation during use. After an investigation, Draeger was able to conclude that the errors were due to impurities introduced for a certain time frame during the manufacturing process.
As of September 9, 2025, Draeger has not reported any serious injuries or deaths related to this issue.
Device Use
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions
Contact Information
Customers in the U.S. with questions about this recall should contact Draeger Service Technical Support at 1-800-437-2437 (press two at the prompt, then two, then two again) between the hours of 8 am and 8 pm (EST).
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.