On August 10, the U.S. Food and Drug Administration (FDA) announced that Boston Scientific had recalled a line of pacemakers. The Class I recall, the most serious classification – issued for products that could cause serious injury or death – affected over 40,000 devices.
According to the FDA announcement, Boston Scientific has recalled the INGENIO family of pacemakers and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps). The recall affects approximately 48,000 devices manufactured and distributed between September 2011 and August 2020.
The full recall by Boston Scientific began on June 3, 2021. This recall included models from the ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL products as well. The model numbers that were recalled were J174, J177, K174, K184, and K187 under product code LWP.
The recalled pacemakers were used in patients who have low heart rates, as well as patients with moderate to severe heart failure. Both conditions prevented the heart from pumping enough blood to meet the body's needs. The pacemakers were designed to improve blood flow to the patient’s body by shocking the heart into a more sustainable rhythm.
Boston Scientific is recalling the pacemakers after discovering the risk of the device unintentionally transitioning to safety mode. Safety mode is intended to provide backup if the device has some kind of fault.
While the device is in safety mode, it may not accurately sense muscle contractions and may lose its sense of pace, jeopardizing the patient’s heart. Additionally, once the device goes into safety mode, the device cannot be reprogrammed and must be replaced, requiring surgeries.
In response to the recall, Boston Scientific has not recommended preventative replacement surgeries unless patients have underlying health issues, pacemaker dependence or problems with pacing.
In order to prevent “unintended consequences,” Boston Scientific has recommended that if shared decision-making supports the consideration of early device replacement, then the EL pacemakers should be replaced when the device has four or fewer years left in service, and the CRT-Ps should be replaced when it has three or fewer years left.