Baxter International Issues Recall for Life2000 Ventilators

On July 10, Baxter International Inc. announced it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. Baxter has received one serious injury complaint potentially related to this issue and is working with customers to replace affected Life2000 ventilator devices.

Damage to the battery charger dongle prevents the ventilator’s internal battery from charging. If the Life2000 ventilator fails to charge or has intermittent charging behavior, this may leave the patient unable to use the device. For patients requiring ventilator support, inability to use the device may result in oxygen desaturation episodes that range from mild to potentially life-threatening. Patients should always have an alternate means of ventilation or oxygen therapy available.

Baxter has contacted affected customers, instructing them to inspect the condition of the battery charger dongle and confirm the device is charging properly. If damage is observed or the battery is not charging properly, patients should contact Baxter Home Care Customer Service to have the device replaced immediately. If no damage is observed and the battery is charging properly, patients may continue to use the ventilator and Baxter will replace the device at the patient’s next scheduled in-home visit with a clinical trainer.

The Urgent Medical Device Recall applies to the Life2000 ventilator with product code MS01-0118 with an attached battery charger dongle. The impacted ventilators were distributed in the United States between Aug. 21, 2023 and April 2, 2024.

Baxter has notified the U.S. Food and Drug Administration (FDA) of this action. Any product quality complaints or adverse events experienced with the use of these products may be reported using one of the following options:

Calling Baxter Home Care Customer Service at 800-426-4224, option 3 between the hours of 7:30 a.m. and 6 p.m. central time, or Baxter Clinical Support at 800-397-9071, which is available 24 hours a day.

Reporting to the FDA MedWatch Serious Injury Reporting Program:

Online: By completing and submitting the report online at: https://www.accessdata.fda.gov/scripts/medwatch/ 

Regular mail or fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.