Accolade Pacemaker Recall Investigation

Accolade pacemaker recall investigation

Migliaccio & Rathod is investigating a recent recall of the Accolade Pacemaker produced by Boston Scientific. If you or a loved one has one of these pacemakers, please get in contact with us to determine if you might have claims against the manufacturer.

On December 16, 2024, the FDA announced that patients with “Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers” will need early replacements of these products.

The Accolade Pacemaker Defect

Boston Scientific, the manufacturer, announced that some of these devices have a bug wherein they will permanently enter safety mode. This is a limited functionality mode and devices that are in it may not properly regulate the rhythm of the heart as intended. The FDA reported that they are working to identify all models that have this bug and to provide additional mitigation strategies to patients.

The FDA recommends that individuals who currently have these pacemakers work with their doctor to monitor the device and determine what the best next steps are.

Already this defect with the pacemakers has been linked to over 800 injuries and 2 deaths.

Do you have an Accolade pacemaker?

If so, we would like to speak with you. Please complete the contact form on this page, send us an email at [email protected], or give us a call at (202) 470-3520 for more information.

The lawyers at Migliaccio & Rathod LLP have years of experience in class action litigation against large corporations, including in cases involving unfair and deceptive trade practices. More information about our current cases and investigations is available on our blog.