Urgent Medical Device Recall Issued for Ventilator After Reported Serious Injury

Urgent Medical Device Recall Issued for Ventilator After Reported Serious Injury

Baxter International Inc. issued an urgent medical device recall for Life2000 ventilators that have an attached battery charger dongle on Wednesday, after the company received a report of a serious injury.

Baxter recalled the ventilators because of reports that the devices aren’t charging properly when the battery charger dongle is damaged, according to an announcement posted on the U.S. Food and Drug Administration’s (FDA) website. The serious injury reported may be related to that problem, and the company said it is working with customers to replace ventilators that have this issue.

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The recall applies to Life2000 ventilators with the product code MS01-0118 that have the attached battery charger dongle, and were distributed in the U.S. from Aug. 21, 2023 to April 2, 2024, according to the recall announcement. The ventilator is typically used to help people who have conditions that can affect the respiratory system, such as chronic obstructive pulmonary disease (COPD), neuromuscular conditions like amyotrophic lateral sclerosis (ALS), or restrictive thoracic disorders.

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The ventilator’s internal battery may not be able to charge if the battery charger dongle is damaged, according to the recall announcement. That could prevent patients from being able to use the device—and for some patients who need ventilators, that could cause oxygen desaturation episodes that could be life-threatening. Baxter recommended that patients have alternate ventilation or oxygen therapy methods on hand in case of emergencies.

Baxter said it has notified both the FDA and customers affected by the issue. The company told affected customers to check the condition of the dongle to ensure the ventilator is charging properly. If customers notice damage or that the battery is not charging, they should contact Baxter Home Care Customer Service to get the ventilator replaced. If they don’t notice any damage or if the battery is charging as it should be, then the device is safe to continue using; Baxter will replace the ventilator when patients have their next in-home visit with a clinical trainer.

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