Draeger expands its correction for Atlan models due to potential mechanical ventilation failure.
The US Food and Drug Administration (FDA) issued an Early Alert regarding a potentially high-risk issue with Draeger Atlan A350 and Atlan 350 XL anesthesia workstations. The agency is notifying the public that Draeger Inc is expanding an October 2024 correction to include additional units due to a manufacturing error that may cause the piston ventilator to fail.
According to the FDA, the manufacturing error could cause mechanical ventilation to fail during use or prevent it from starting if the error occurs in standby or system test mode. If the ventilator fails during a procedure, the device displays a “Ventilator error!!!” message. Manual ventilation and spontaneous breathing remain possible in both scenarios, though manual intervention may be necessary to prevent patient injury.
The use of affected workstations may lead to serious health consequences, including lack of oxygen, slow heart rate, cardiac arrest, and death. As of May 6, 2026, there have been no reported injuries or deaths associated with this issue, according to the FDA alert.
On May 7, Draeger sent a letter to affected customers recommending that the workstations only be used under permanent supervision until the ventilator motor assembly is replaced. If mechanical ventilation fails, the FDA recommends users switch to manual ventilation mode, monitor the patient’s oxygenation status, and notify all relevant personnel within the organization.
Draeger will replace the ventilator motor assembly on all affected devices. Local service representatives will contact customers to schedule the replacement, according to the alert.
Affected products include the Atlan A350 and the Atlan A350 XL. Customers in the US with questions or quality problems should contact Draeger service technical support at 1-800-437-2437.
