Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable

This recall involves correcting 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.  

Affected Product

• Product Names: Life2000 Ventilator System
• Model/Unique Device Identifier (UDI): 
  • Model #  |  Unique Device Identifier (UDI): 
    • REF BT-20-0002  |  UDI/DI 00887761978201
    • REF BT-20-0002A and REF BT-20-0002AP  |  UDI/DI 00887761981638
    • MS-01-0118  |  UDI/DI 00887761978089
    • MS-01-0118  |  UDI/DI 00815410020537
• Lot/Serial Numbers: See Attachment A

What to Do

• Always have an alternate means of ventilation or oxygen therapy available.
• Patients may continue using the Life2000 ventilator if it is functioning correctly.

On December 20, 2024, Baxter Healthcare Corporation sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

• If you received this communication directly from Baxter, acknowledge receipt of this letter, even if you do not have any remaining inventory.
  • If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification.
• If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication.

Reason for Recall

Baxter Healthcare Corporation is correcting the Life2000 Ventilator System due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable. This is a result of a failed crimping operation during manufacturing that caused the crimp to puncture the insulation of the charger connector, thus resulting in an audible and visual alarm, which when engaged makes the ventilator inoperable. The alarm is a high-pitched sound with repetitive beeping and a visual red flashing LED icon, alerting the user to an issue with the device. Baxter has corrected the issue, and a Baxter representative will provide a replacement charger as well as arrange for the return of the defective battery charger.

The use of affected product may cause serious adverse health consequences, including deterioration in respiratory status, leading to hypoxia (lack of oxygen), with resulting cognitive impairment (confusion), lethargy, changes in blood pressure and heart function, or even coma and death.

If the patient is not quickly transitioned to an alternate means of ventilation or oxygen therapy, further lung damage could occur depending on the user’s pre-existing medical condition and access to their recommended back-up device or oxygen therapy.

There have been no reported injuries. There have been no reports of death. 

Device Use

The Life2000 Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

Contact Information

Customers in the U.S. with questions about this recall should contact Baxter Advanced Respiratory, Home Care Customer Service team at 800-426-4224, option 3, between the hours of 7:30 a.m. and 6:00 p.m. Central Time, Monday through Friday. Alternatively, contact Baxter Advanced Respiratory, Clinical Support team at 800-397-9071.

Health care providers with questions about this recall should contact Baxter Advanced Respiratory team at 800-426-4224, option 2, then option 1, between the hours of 8:00 a.m. and 6:00 p.m. Central Time, Monday through Friday.

Additional FDA Resources

• FDA’s Enforcement Report
• Medical Device Recall Database
  • Class 1 Device Recall Welch Allyn, Inc., Life 2000
  • Class 1 Device Recall Welch Allyn, Inc., Life 2000
  • Class 1 Device Recall Breathe Technologies, Inc., Life2000

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.