Baxter is recalling the Life2000 Ventilation System due to a cybersecurity issue discovered through internal testing, the FDA reports.
The Life2000 Ventilation System is intended to provide continuous or intermittent breathing support for people who require mechanical ventilation assistance. Specifically, the system is used for adult patients who require positive pressure ventilation delivered through an endotracheal tube or a mask. The system includes both the Life2000 Ventilator and the Life2000 Compressor.
According to the FDA, if an unauthorized person were to gain physical access to an unattended device, 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.
Use of the affected product may cause serious adverse health consequences, including injuries caused by device malfunction or complete failure of vital breathing support and death, according to the FDA.
As of April 10, 2025, Baxter has reported no serious injuries or deaths associated with this issue, the FDA says.
Affected Product
- 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. 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 [email protected], 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].
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
