The FDA has designated Boston Scientific’s software correction for its Accolade family of pacemakers a Class I recall — the agency’s most serious category, reserved for situations in which use of a device can cause serious injury or death. The action covers two paired records initiated March 19, 2026, that together reach 1,404,232 implanted devices worldwide.
This is a software correction, not a device removal. No one is being asked to explant a working pacemaker. Boston Scientific is distributing a software update, Brady Software Maintenance Release 6 (SMR6), to be applied during routine in-office device-check appointments across the Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude lines.
The FDA’s posted guidance is that prophylactic replacement before high battery impedance is confirmed is not recommended. Patients should keep their scheduled device checks and talk to their care team — not seek pre-emptive replacement surgery.
What can go wrong
The root issue is a battery problem, not a coding bug. In late 2024, Boston Scientific identified a subpopulation of Accolade pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) with an increased potential to enter Safety Mode during telemetry because of high internal battery impedance. Safety Mode limits pacing functionality. An earlier release (SMR5) disabled wandless ZIP telemetry to keep ambulatory devices out of Safety Mode, but the manufacturer and the Heart Rhythm Society notice describe residual behaviors that SMR6 is meant to resolve — including incomplete ZIP disablement, magnet-induced false-positive battery-impedance testing, and a “prolonged voltage recovery state” that can leave battery diagnostics stuck. The advisory population has now expanded to include all Accolade CRT-P and dual-chamber extended-life (DR-EL) devices, which face a risk of early replacement.
According to the FDA correction notice as reported by trade press, Boston Scientific had reported four deaths and 2,557 serious injuries associated with this issue as of March 18, 2026. The Heart Rhythm Society’s clinician notice independently describes the four deaths: three patients whose devices entered Safety Mode from high battery impedance had syncope requiring hospitalization and later died, and one patient died after a replacement procedure. (See the verification note below regarding the serious-injury figure.)
The two underlying recall records are classified and reachable through the openFDA enforcement database. The lead record (Z-1770-2026), covering non-CRT pacemakers, lists 718,456 units in commerce and is marked “Open, Classified”; the companion CRT-P record (Z-1771-2026) covers another 685,776 units, for a combined 1,404,232 devices. Both were initiated March 19, 2026, posted April 24, 2026, and distributed worldwide.
The FDA’s posted guidance is measured. Prophylactic replacement before confirming high battery impedance is not recommended. Patients at risk who have not yet received the prior SMR5 update should, per the notice, schedule prompt in-person follow-up if four or fewer years of device longevity remain; everyone else should keep to the standard follow-up cadence. Patients can check whether a device is affected by model and serial number through Boston Scientific’s lookup tool. This is reporting on a regulatory action, not medical advice — clinicians and patients should follow the manufacturer notice and their own care team.
Verification note: On review, the cited CDRH recall front-end record (res.cfm?id=219239) and the FDA correction page returned errors to automated retrieval, so the device counts, dates, classification, and correction mechanism here are taken directly from the openFDA enforcement records (Z-1770-2026, Z-1771-2026). The four deaths and the “no prophylactic replacement” guidance are confirmed by the Heart Rhythm Society’s primary clinician notice. The “2,557 serious injuries as of March 18, 2026” figure could not be reconfirmed against a directly reachable FDA primary page and is attributed to the FDA correction notice as reported by trade media (MassDevice, Becker’s, Cardiovascular Business).