The FDA this week labeled recalls of particular ventilators from Philips (NYSE: PHG), Baxter (NYSE:BAX), and Zoll Medical as Class I, the most serious kind of recall.
The recalls add to a string of tough news for the ventilators market, just years after it was in high demand during the COVID-19 pandemic. Earlier this year, medtech giant Medtronic said it would exit the ventilator market, citing the unprofitability of its product lines.
Philips, meanwhile, is still grappling with a host of serious recalls related to its Respironics business products, including ventilators. In January, Philips discontinued the U.S. sales of several respiratory device product lines as it neared completion of a consent decree with the U.S. Department of Justice and FDA. Last week, it announced the downsizing of Respironics operations in Pennsylvania.
The FDA’s latest Class I recall announcement for Philips involves potential Ventilator Inoperative alarm failures on BiPAP V30, BiPAP A30, BiPAP A40 devices. The FDA said there have been 10 reports of injuries and seven reports of death related to the recall. (Clarification: this article was updated on July 12, 2024, to reflect the correct injury and death reports after the FDA issued a correction).
Philips Respironics sent customers an urgent medical device recall notice on March 26, requiring them to update their use instructions for the products. The company instructed health providers that in the case of a Ventilator Inoperative alarm, they should immediately remove a patient from a device and connect them to an alternate source of ventilation, if available. As an optional step/action, they could perform a “hard reboot” (forced device restart) that may temporarily restore the device’s function.
An additional Class I recall announcement today involved Ventilator Inoperative alarm failures with OmniLab Advanced+ (OLA+) ventilators. An April 1 urgent medical device recall notice included similar instructions for health providers as the other recall. It also said they could contact Philips for a software patch for the problem. The FDA said there have been 15 reported injuries and one report of death related to the recall.
The FDA has additional information on its website.
Baxter’s recall of the Live2000 ventilator
Baxter’s Class I recall involves the Live2000, which is contained within the company’s Life2000 ventilator system. The company issued a warning for that system last year due to potential oxygen desaturation.
According to the FDA, the company identified the potential for Life2000 ventilator systems to either fail to charge or have intermittent charging behavior. The company attributed this to damage to the battery charger dongle. Damage to this prevents the ventilator’s internal battery from charging. The matter remains under investigation by the FDA, which hasn’t yet provided a determined cause.
The FDA says 2,510 units of the ventilators are currently in commerce in the U.S.
Baxter notified consignees on May 29 with an urgent medical device recall letter. It instructed customers to ensure an alternate means of ventilation or oxygen therapy. They should also inspect the charger dongle for damage and replace immediately if they identify damage.
Patients may continue to use the system if an inspection confirms no damage to the dongle and appropriate battery charging. The company also asked patients to observe any alarms and notify Baxter’s customer service if in need of assistance. Baxter agreed to replace ventilators upon the customer’s next scheduled in-home visit with a clinical trainer.
Zoll Medical is also sending out urgent instruction updates for ventilators
Zoll Medical’s Class I recall covers 731 of its MRI-compatible 731 Zoll ventilators, models AEV, EMV+ and Eagle II. In a June 12 Urgent Corrective Action notice, it requested that health providers dispose of all old versions of affected Operator’s Guides and/or Quick Reference Guides for the machines.
According to Zoll and the FDA, important information was accidentally left out of the older versions of the guides. The missing information might result in users placing the ventilator too close to the MRI machine, which could cause the ventilator to trigger alarms, malfunction, or unexpectedly shut down. The FDA said there were no reports of injuries or deaths related to the recall.
Associate Editor Sean Whooley contributed to this report. This story originally ran on June 27, 2024. Update June 28 with information on additional recalls.
