FDA elevates Philips cardiac telemetry recall over unflagged ECG alerts, following 2 deaths

The FDA is elevating a recall from Philips related to one of its wearable outpatient heart monitors, used to help detect cases of hidden, transient arrhythmias that may only last minutes at a time.

According to Philips and its Braemar Manufacturing subsidiary, they found that some cardiac events recorded by electrocardiogram were not correctly flagged and routed to clinicians for full review. Between July 2022 and July 2024, this included episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second- or third-degree atrioventricular block.

The FDA said it has received reports of 109 injuries and two deaths related to the issue, linked to the system's monitoring software. The agency classified the recall as Class I, which is the most serious, though no hardware needs to be returned to the company and no software updates are necessary.

Philips alerted healthcare providers using its Mobile Cardiac Telemetry Monitoring service, or MCOT, and the BTPS-1000 wearable sensor patch in November 2024, saying that it had collected a list of potentially affected patients on a secure website.

There, clinicians can request for their ECG reports to be reprocessed and reanalyzed. Philips said that it did not plan to reach out directly to patients regarding the issue.

“If patients have been impacted as part of this issue, health care providers have the responsibility to inform patients and/or update a patient’s care pathway,” the FDA said in its notice.

The agency estimates that about 130,000 of the MCOT patches have been distributed in the U.S., to more than 41,200 customers.

"Acting fast on post market surveillance signals, we proactively identified a software configuration issue and reported a medical device correction, offering clinicians the possibility of reprocessing potentially affected prescriptions," Philips said in a statement. "The service is now working normally, and with patient safety as our number one priority we continue to methodically work through quality at all levels in a multi-year program."