The U.S. Food and Drug Administration (FDA) has announced a Class I Recall—the most serious type—for the Baxter Life2000 Ventilation System (which includes the Ventilator and Compressor) following the manufacturer’s decision to remove the device from the market permanently. This critical safety action is being taken due to a significant cybersecurity vulnerability that poses a risk of serious injury or death.
What is the Life2000 Ventilation System?
The Life2000 Ventilation System is a crucial medical device intended to deliver continuous or intermittent breathing support for adult patients who require mechanical ventilation, typically through an endotracheal tube or a mask. It is approved for use in both home and institutional settings.
The Reason for the Permanent Removal: Cybersecurity Risk
Baxter is permanently recalling and removing all Life2000 Ventilation Systems due to a cybersecurity issue discovered during internal testing.
- The Vulnerability: The core issue is that if an unauthorized person gains physical access to an unattended device, they could potentially:
- Change life-supporting therapy settings.
- Access device data.
- The Danger: If therapy settings are maliciously or accidentally altered, the device’s essential life-supporting air delivery function could fail, leading to serious adverse health consequences, including death.
The FDA has classified this as a Class I Recall, which is reserved for situations where there is a reasonable probability that using the product will cause serious adverse health consequences or death.
While Baxter has reported no serious injuries or deaths associated with this specific cybersecurity vulnerability as of April 10, 2025, the potential for harm mandates this urgent, permanent removal.
Immediate Action Required for Patients and Providers
Baxter has initiated the permanent removal process for all affected devices. If you or someone you know is using a Life2000 Ventilation System, the following actions are critical:
- Do NOT discontinue use immediately unless advised by your healthcare provider. The primary step is to contact your healthcare provider to discuss and arrange for an alternative, replacement ventilation system.
- Maintain Physical Control: Do not leave Life2000 Ventilation Systems unattended in public or unsecured areas. Maintaining physical control reduces the likelihood of unauthorized access.
- Report Concerns: If you suspect the device has been exposed to unauthorized personnel, contact your healthcare team immediately, and then contact Baxter Advanced Respiratory Home Care Customer Service.
- Arrange for Return: Once an alternative therapy and medical equipment supplier has been identified, contact the appropriate Baxter customer service team to arrange the permanent return of the Life2000 system.
This permanent removal supersedes previous device corrections and emphasizes the need for a swift transition to an alternative, secure life-support system.
For more information, please refer to the official FDA recall alert and communications from Baxter Healthcare Corporation.
