Baxter International has issued an urgent medical device recall for Life2000 ventilators over potential damage to the attached battery charger dongle.
The Life 2000 Ventilator is a non-invasive ventilator designed for home use, offering breathing support without the need for a mask.
Its lightweight and highly portable design allows patients to receive necessary breathing assistance while carrying out their daily activities.
The recall is based on reports that the devices may not charge correctly if the battery charger dongle is damaged.
The American multinational healthcare company has received one serious injury report possibly linked to this issue.
Baxter has informed the US Food and Drug Administration (FDA) about this recall initiative.
According to the US FDA, damage to the battery charger dongle can prevent the ventilator’s internal battery from charging.
Failure of the Life2000 ventilator to charge properly or sporadic charging behaviour could potentially prevent patients from using the device.
The device’s inability to use the device could lead to episodes of oxygen desaturation, ranging from mild to potentially life-threatening, for patients reliant on ventilator support.
FDA said the patients should always have an alternative means of ventilation or oxygen therapy.
Baxter International has reached out to affected customers, advising them to inspect the condition of the battery charger dongle and ensure proper charging of the device.
If any damage is detected or if the device fails to charge correctly, patients are urged to contact Baxter Home Care Customer Service immediately for a replacement.
Baxter is planning to arrange a replacement during their next scheduled in-home visit with a clinical trainer.
Patients who find no damage and confirm proper charging may continue using the ventilator, the healthcare firm said.
The Urgent Medical Device Recall pertains to the Life2000 ventilator identified by product code MS01-0118, including those distributed in the US from 21 August 2023 to 02 April 2024.
The recall closely follows Baxter’s talks to divest its kidney-care spin-off Vantive to private equity firm Carlyle Group for more than $4bn, including debt.
