Dive Brief:
- Baxter has recalled Life2000 ventilation systems due to the risk of devices failing to charge or intermittently charging.
- The recall affects more than 2,500 units distributed in the U.S., according to a June 26 entry in the Food and Drug Administration’s recall database. The FDA labeled the recall as a Class I event, the agency’s severest classification.
- Baxter did not immediately respond to MedTech Dive’s request for comment. The Life2000 system was also part of a Class I recall last year.
Dive Insight:
The Life2000 Ventilation System is a portable ventilator for patients who have chronic respiratory failure or other medical issues that may affect their breathing. Baxter acquired the product through its $10.5 billion purchase of Hillrom in 2021.
The issue stems from damages to the battery charger dongles, which can prevent the ventilator's internal battery from charging. Baxter notified customers, including patients and providers, of the recall on May 29, warning them to check for damaged battery charger dongles, according to the FDA’s database entry. The company advised customers to have an alternate ventilator or oxygen device ready to use and immediately replace any damaged chargers.
Customers were also asked to watch for alarms from the system. Patients can continue to use the devices if there is no damage to the dongle and the battery is charging appropriately. The entry stated that Baxter would replace damaged ventilator devices at patients’ next scheduled in-home visit with a clinical trainer.
The company also recalled thousands of Life2000 systems in 2023 due to the risk of patient oxygen desaturation when devices are connected to third-party oxygen concentrators. At the time, Baxter said it received no reports of death related to the safety problem, though there were reports of hospitalizations.
Life2000 is not the first Hillrom device Baxter was forced to recall since the acquisition: In 2022, Baxter recalled the Volara ventilator system after one injury and two deaths were tied to a device malfunction.
