Ingenio Pacemaker, CRT-P Recall Issued After Dozens of Incidents and Patient Injuries

Following reports of severe and potentially life-threatening injuries, a recall has been issued for certain Boston Scientific pacemakers, which may suddenly stop providing critical heart pacing therapy.

The FDA announced a Boston Scientific INGENIO pacemaker recall on August 6, indicating there have been at least 65 reports of the pacemakers suddenly switching to “safety mode”, causing a loss of pacing or ability to regulate the patient’s heart rate.

Pacemakers are implantable devices positioned under the skin and are designed to assist the heart’s pumping action to treat fast, irregular, or slow heart rhythms, by applying small electric pulses to either one or both sides of the heart to keep the left and right chambers beating in proper sync. The devices are also used to treat patients susceptible to heart failure by improving the body’s ability to pump blood and distribute oxygen.

The recall includes Boston Scientific’s INGENIO family of pacemakers and CRT-Ps marked with model numbers J174, J177, K174, K184, and K187 and product code LWP. The devices were manufactured by Boston Scientific of Marlborough, Massachusetts from November 1, 2011 through August 1, 2020. About 48,000 devices are affected.

According to an Important Medical Device Advisory issued by Boston Scientific on June 3, the manufacturer knows of at least 65 incidents, including three serious injuries, in which the pacemakers have incorrectly and suddenly transitioned to safety mode, which is intended to provide backup functionality if the device is faulty. No deaths have been linked to the malfunction.

The FDA warns that when the device unintentionally switches to safety mode there could be a reduced pacing ability and inability to regulate a patient’s heart rate, which could lead to serious or life threatening injuries. If the device goes into safety mode, the device cannot be reprogrammed, requiring early device replacement procedures, officials warn.

Boston Scientific and the FDA do not recommend proactively replacing the pacemakers at this time, and replacement procedures should only occur if the device experiences the defect and switches to safety mode on its own. The agency and the manufacturer are asking healthcare professionals to assess specific patient risk factors including underlying health issues, pacemaker dependence, or problems with pacing to prevent unintended outcomes.

Patients with the recalled pacemakers should be closely monitored and have a system follow-up remotely or in person at least every 12 months, according to Boston Scientific’s recommendations.

The FDA has categorized the recall as a Class I recall, indicating it is the most serious of its kind, and that the use of the device has a high probability of causing severe patient injury or death.

The FDA requests any health care professionals or patients who experience a problem with the recalled pacemakers file a report with the FDA’s MedWatch adverse event reporting program.