Urgent Recall: Baxter Life2000 Ventilator Permanently Removed Due to Cybersecurity Threat

Baxter Recalls Life2000 Ventilation System Over Cybersecurity Vulnerability

Baxter is recalling the Life2000 Ventilation System after internal testing uncovered a cybersecurity issue, as reported by the FDA. This system is designed to provide continuous or intermittent breathing support for adults needing mechanical ventilation via an endotracheal tube or mask, including both the Life2000 Ventilator and Life2000 Compressor.

If an unauthorized person gains physical access to an unattended device, they could alter therapy settings or access device data, potentially causing the life-supporting air delivery to malfunction. This could lead to serious adverse health consequences, such as injuries from device failure or even death. As of April 10, 2025, no serious injuries or deaths have been reported.

Affected Product Details

• Product Name: Life2000 Ventilation System

| Product Code | UDI-DI Number | Product Code on Shipping Carton | Product Description | Serial Numbers | |--------------|---------------|----------------------------------|---------------------|----------------| | MS-01-0100 | 00815410020278 | BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT200007, BT-20-0011, BT200011, and RMS010118CP | Life2000 Ventilator | All | | MS-01-0118 | 00887761978089 or 00815410020537 | BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT200007, BT-20-0011, BT200011, and RMS010118CP | Life2000 Ventilator | All | | MS-01-0093 | 00887761978072 or 00815410020292 | BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP | Life2000 Compressor | All | | MS-01-0121 | 00887761978041 | BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP | Life2000 Compressor | All | | MS-01-0125 | 00887761976283 | BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP | Life2000 Compressor | All |

FDA Recommendations

Stop using Life2000 ventilators immediately. Patients should contact their healthcare provider to discuss replacement options and avoid leaving devices unattended in public or unsecured areas.

On April 10, 2025, Baxter issued an Urgent Medical Device Recall letter with specific actions:

• For home patients:
  • Reach out to your healthcare provider for therapy replacement and transfer care to an alternative supplier.
  • Contact Baxter Advanced Respiratory, Inc. Home Care Customer Service at 800-426-4224 option 3 to arrange permanent return of the system.
  • Do not leave the system unattended; maintain physical control to prevent unauthorized access.
  • If unauthorized access is suspected, contact your healthcare team and Baxter to verify settings and performance.
  • Acknowledge receipt if communication came from Baxter via the Patient Reply Instruction Sheet.
  • For communications from other suppliers, respond as instructed and direct questions to them.

• For healthcare-related customers (facilities, DME suppliers, distributors):
  • Locate and discontinue use of all Life2000 ventilators and compressors.
  • Keep devices secured and under control to reduce unauthorized access risks.
  • If exposure to unauthorized personnel is suspected, contact Baxter Acute Care Customer Service at 800-426-4224 option 2, then option 1 or email HRC_ACCS_Web@baxter.com for verification.
  • Forward this communication to relevant departments.

• For DME suppliers:
  • Notify patients using Life2000 ventilators of the recall.
  • Assist in identifying alternate therapy options with patients and prescribers.

• For distributors:
  • Disseminate this information and conduct a user-level recall of affected products.

Baxter will continue providing replacement chargers for battery charger failures from a previous correction until all Life2000 ventilators are removed, but no updates will be made for prior corrections.

Contact Information

Customers in the U.S. with questions should contact:

• Home care customers and/or patients: Home Care Customer Service 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 at 800-426-4224 option 2, then option 1.