Recall Z-0098-2026— Boston Scientific Corporation

Name: FDA recall Z-0098-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-20

Class I · Ongoing

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2025-08-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Model Number S701 ALTRUA 2 SR SL Pacemaker. Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)..

Recalling firm: Boston Scientific Corporation
Classification: Class I
Status: Ongoing
Initiated: 2025-08-20
Firm location: Saint Paul, MN, United States

Product description

Model Number S701 ALTRUA 2 SR SL Pacemaker

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Data sourced from openFDA. This site is unofficial and independent of the FDA.