Class I Recall for Boston Scientific Ingenio Pacemaker and CRT Devices

Boston Scientific is recalling its Ingenio suite of pacemakers and cardiac resynchronization devices due to the risk of an “incorrect transition to safety mode,” the US Food and Drug Administration noted Friday, categorizing the action as a Class I recall, the most serious type.

The family of pacemakers affected includes the Advantio DR EL, the Ingenio DR EL, and the Viatlio DR EL. 

As the FDA alert explains, the purpose of the safety mode is to provide backup if the device is faulty; however, safety mode is only intended for emergency use, since it brings with it the risk of inappropriate loss of pacing due to sensing of muscle contractions. Moreover, “if the device incorrectly goes into safety mode, the device cannot be reprogrammed and must be replaced,” the recall notice explains. “The use of affected product may cause serious adverse health consequences, including loss of pacing or ability to regulate heart rate, worsening of heart failure, and death.”

In total, 65 events have been reported, including three injuries requiring patients to receive temporary external pacing. No patients have died. 

Boston Scientific initiated the recall back in early June 2021 for product code LWP and model numbers J174, J177, K174, K184, and K187. Devices were manufactured between September 2011 and December 2018, distributed between November 1, 2011, and August 1, 2020.

At least 48,000 devices in the United States are affected by the recall. The company is advising physicians to consider patient-specific factors, including underlying health issues and pacemaker dependence, when assessing the potential risk should the device inappropriately switch to safety mode. Any patients who experience an inappropriate transition to safety mode should be scheduled for device replacement. In addition, specific factors related to EL pacemakers and cardiac resynchronization devices, which are detailed in the notice, should be taken into consideration.