Recall Alert: Baxter Permanently Removes Life2000 Ventilation System

This recall involves removing certain devices 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.

Affected Product

• Product Name: Life2000 Ventilation System

What to Do

Stop using Life2000 ventilators. Patients should reach out to their healthcare provider to discuss replacement options. Do not leave ventilators unattended in public or unsecured areas.

On April 10, 2025, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

• For home patients:
  • Reach out to your healthcare provider to discuss therapy replacement options and transfer care to an alternative medical equipment supplier.
  • Once alternative therapy and medical equipment suppliers have been identified, contact Baxter Advanced Respiratory, Inc, Home Care Customer Service at 800-426-4224 option 3, to arrange for the permanent return of the Life2000 Ventilation System.
  • Do not leave Life2000 Ventilation Systems unattended in public or unsecured areas. Maintaining physical possession and control of the ventilator reduces the likelihood of an unauthorized person gaining access to the device.
  • If you suspect your device has been exposed to an unauthorized person, contact your healthcare team and then contact Baxter Advanced Respiratory Home Care Customer Service to verify the device settings are correct and that the device is performing as expected.
  • If communication came from Baxter, acknowledge receipt by following instructions on the Patient Reply Instruction Sheet that was enclosed with the letter.
  • For patients who received communication through another medical equipment supplier (other than Baxter), respond to your supplier according to their instructions. Any questions about a supplier’s communication should be sent to that supplier.
• For all healthcare-related customers (health care facilities, DME suppliers, and distributors):
  • Locate and discontinue use of all Life2000 ventilators and compressors within the facility.
  • Do not leave Life2000 Ventilation System unattended in public or unsecured areas. Maintaining physical possession and control of the ventilator reduces the likelihood of an unauthorized person gaining access to the device.
  • If you suspect that a device has been exposed to unauthorized personnel, contact Baxter Acute Care Customer Service team. The team can help verify whether the device settings are correct and if the device is performing as expected. The team can be reached by email at HRC_ACCS_Web@baxter.com, or by phone at 800-426-4224, option 2, then option 1.
  • Forward this communication to any departments within the institution who use the affected product.
• For DME suppliers:
  • Notify patients using Life2000 ventilators of this recall.
  • Work with patients and prescribers to identify an alternate therapy option.
• For distributors:
  • Disseminate this information and conduct a user-level recall of the affected product distributed to customers.

Baxter will continue to provide replacement chargers for people who experience a battery charger failure related to the previous correction, Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator Due to a Nonconforming Battery Charger [02/05/2025], until all Life2000 ventilators are removed from use. However, the firm will not update affected devices related to the prior correction, Baxter Healthcare Updates Use Instructions for Life2000 Ventilation System Due to Risk of No Low Gas Pressure Alarm [10/24/2024].

Reason for Recall

Baxter is recalling the Life2000 Ventilation System due to a cybersecurity issue discovered through internal testing. If an unauthorized person were to gain physical access to the device while it is unattended, they could potentially change device therapy settings or access device data. This may lead to the life-supporting air delivery function not working as intended.  

The use of affected product may cause serious adverse health consequences, including injuries caused by device malfunction or complete failure of vital breathing support and death.  

As of April 10, 2025, Baxter has reported no serious injuries or deaths associated with this issue.

Device Use

The Life2000 Ventilation System is intended to provide continuous or intermittent breathing support for people who require mechanical ventilation assistance. The system includes both the Life2000 Ventilator and the Life2000 Compressor. It is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the system is used for adult patients who require positive pressure ventilation delivered through an endotracheal tube or a mask. The Life2000 Ventilation System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

Contact Information

Customers in the U.S. with questions about this recall should contact:  

• Home care customers and/or patients: Home Care Customer Service team at 800-426-4224, option 3, or Baxter Clinical Support at 800-397-9071.
• Healthcare providers, DME suppliers, and distributors: Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1

Additional FDA Resources:  

Additional Company Resources (listed in order of most to least recent):  

Company provided information on a recall is posted here by the FDA as a public service.

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 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.