7 Types of Pacemakers Have Been Recalled with Advice for “Early Replacement”
Roughly 3 million Americans are currently living with a pacemaker, and according to the American Heart Association (AHA), 600,000 new pacemakers are implanted each year. Now, a breaking recall suggests those patients should check in with their doctors, after two deaths have been reported following device failure.
On December 16, The U.S. Food and Drug Administration (FDA) notified patients, caregivers, and healthcare providers of a malfunction affecting select pacemaker devices made by Boston Scientific Corporation (Boston Scientific) Accolade. These include the following pacemakers: the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers.
Pacemakers and cardiac resynchronization therapy pacemakers are small, battery-powered devices that are surgically implanted in the chest or abdomen to help regulate the heart’s rhythm and rate. Most often, they are used to treat abnormal heartbeat or heart failure.
The safety warning was initiated when the company identified that some of their devices had an increased risk to permanently enter Safety Mode, “which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients.” This occurs due to “latent high battery impedance,” or an inability to produce sufficient electrical current, thereby compromising device function.
According to a separate notice issued by Boston Scientific, a subset of approximately 13% of the company’s devices could be affected by the malfunction. Those with older devices may be at higher risk of a problem, the company adds. “The susceptibility of experiencing a high battery impedance and entering Safety Mode has been observed when the device reaches approximately four years or less of remaining battery longevity,” they write. The devices are also designed to enter Safety Mode if three system resets occur within a 48-hour period.
