The troubled ventilator market has hit another regulatory obstacle after the US Food and Drug Administration (FDA) tagged a recall of Baxter’s respiratory devices as Class I.
Class I indicates the agency’s most serious designation for a recall, meaning continued use of the products, without actions being taken, could cause serious injury or death.
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The recall involves Baxter’s Life2000 ventilator devices, of which there are over 2,500 currently in commerce, according to the FDA’s recall database.
Baxter initiated the recall at the end of last month after reports the systems were failing to charge due to damage to the battery charger dongle. This issue was also causing devices to have “intermittent changing behaviour”.
In a letter to customers, the company said to ensure patients using the systems have an alternate therapy available. The battery dongle should be checked for damage and replaced immediately if so. Baxter said it would replace ventilator devices during scheduled in-home visits with a clinical trainer.
The Life2000 ventilation system is a portable ventilator for patients who have chronic respiratory failure or other breathing-associated medical issues. Baxter acquired the brand when it acquired Hillrom for $10.5bn in 2021.
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By GlobalDataBaxter recalled the Life2000 systems last year due to the risk of patient low oxygen saturation when the devices are connected to third-party oxygen concentrators. Some patients needed hospitalisation due to oxygen desaturation.
In 2022, Baxter recalled the Volara ventilator system – also manufactured by Hillrom – after one injury and two deaths resulting from the device not delivering enough oxygen to patients.
The ventilator market has taken a hit in recent years due to Philips’s mass recalls. According to an FDA notice posted this week, the company’s bilevel-positive airway pressure (BiPAP) machines have now been linked to reports of 952 injuries and 65 deaths.
