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FDA device recallVulnerabilitiesPublished Apr 24, 2026

Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt)

Updated under an hour ago ()

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

Tags
FDA recall, medical device, class 3, Unknown, Nonconforming Material/Component, Open, Classified
Related exam domains
CISSP 3: Security Architecture and Engineering; CISSP 7: Security Operations; CISSP 8: Software Development Security
Source record id
Z-1770-2026
First seen by InfoSec Signals
Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.

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