FDA Issues Class I Recall for Boston Scientific ACCOLADE Pacemakers After 4 Deaths, 2,557 Injuries

A battery manufacturing defect can permanently lock affected devices into a limited-function Safety Mode; the Brady SMR6 software update applied by a clinician prevents future Safety Mode entry but cannot reverse it — devices already in Safety Mode require clinical assessment and may need replacement.

The Food and Drug Administration has classified its correction notice for Boston Scientific ACCOLADE and ACCOLADE EL pacemakers as a Class I recall — its most serious category — following reports of four deaths and 2,557 injuries linked to a battery manufacturing defect that can lock certain devices into a permanent, limited-function Safety Mode.

The Defect

The affected product family includes the ACCOLADE, ACCOLADE EL, ANTHEM, and several related Boston Scientific cardiac rhythm management models. A manufacturing issue in a subset of battery lots can cause the pacemaker to activate Safety Mode permanently — a fallback pacing state designed for temporary use during interrogation or in emergency situations — without the ability to return to normal programmed operation.

In Safety Mode, the device delivers fixed-rate ventricular pacing regardless of the patient’s native rhythm and cannot be reprogrammed through a standard programmer. For pacemaker-dependent patients — those who rely on device support to maintain an adequate heart rate — a permanent Safety Mode lock presents a risk of pacing that does not match their clinical needs. The device continues to deliver pacing, but at a fixed rate that may be incompatible with changing metabolic demands.

Remediation

Boston Scientific has developed and distributed a software update that prevents affected devices from entering permanent Safety Mode. The update must be applied by a qualified clinician or cardiac electrophysiology technician using a compatible programmer during a scheduled appointment. Remote application is not possible.

The company has notified healthcare providers and identified affected devices by serial number to enable systematic patient follow-up. Affected patients should receive direct communication from their device clinic or cardiologist.

Patients with an implanted pacemaker should not alter their clinical care schedule based on media reports. The FDA and Boston Scientific have asked providers to contact affected patients proactively. For patients whose devices have not yet entered Safety Mode, the Brady SMR6 software update is the correction and no device replacement is needed. Patients whose devices have already permanently entered Safety Mode should contact their cardiologist or electrophysiology clinic promptly — software cannot reverse Safety Mode once it has occurred, and device replacement may be required.

The FDA’s Class I classification reflects that there is a reasonable probability that use of the product could cause serious adverse health consequences — not that all affected devices have already failed. Patients whose devices have already received the software update are not at residual risk from this specific defect.

Boston Scientific ACCOLADE Class I Recall, Z-1770-2026. FDA CDRH recall and safety communication database, June 2026.

Correction (June 21, 2026): An earlier version of this article’s dek stated “the only remediation is a software update that must be applied by a clinician in person,” and a front-matter claim stated Safety Mode “cannot be exited without a clinician-applied software update.” The Brady SMR6 software update prevents devices from entering Safety Mode in future but cannot reverse Safety Mode in devices that have already permanently entered it — those patients require clinical assessment and may require device replacement. The dek, front-matter claim, and patient callout have been corrected.

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Reported and written by Dr. Nadia Haq, Devices & Diagnostics Desk, then each load-bearing claim was bound to the primary source it rests on and checked out-of-band against that source before publication. The full mapping is below — nothing here is taken on faith.

The FDA has classified the Boston Scientific ACCOLADE pacemaker correction as a Class I recall following reports of 4 deaths and 2,557 injuries linked to a battery manufacturing defect.

regulatory openFDA device recall — Boston Scientific ACCOLADE pacemakers, recall number Z-1770-2026 Z-1770-2026

The defect can cause affected devices to permanently enter Safety Mode, a limited-function fallback state; the Brady SMR6 software update prevents future Safety Mode entry but cannot reverse Safety Mode in devices that have already permanently entered it — those require device replacement.

regulatory Boston Scientific Urgent Field Safety Notice — ACCOLADE/ANTHEM pacemaker battery Safety Mode, June 2026 boston-scientific-FSN-ACCOLADE-june2026

After publication, a separate AI panel re-verifies every edition against these same sources. The running claim-confirmation rate and every correction are public on the accuracy ledger.