FDA (Devices) recall action 97467
The FDA (Devices) publishes a recall like this one as 27 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 27 pages.
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).
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).
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Boston Scientific is recalling 34,180 ACCOLADE DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 41,009 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 41,191 VISIONIST CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 4,841 ALTRUA 2 SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 223,163 ESSENTIO DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 90,931 ACCOLADE DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 3,376 ALTRUA 2 DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 7,488 ACCOLADE DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 32,695 ACCOLADE DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 16,077 ACCOLADE SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 61,700 ESSENTIO SR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 28,911 VALITUDE CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 12,326 VISIONIST CRT-P EL devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 106,536 PROPONENT DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 190,088 ESSENTIO DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 3,146 PROPONENT DR (VDD) SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 63,851 PROPONENT DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 50,135 ACCOLADE SR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 2,426 PROPONENT DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 10,833 ESSENTIO DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 3,620 VALITUDE CRT-P EL devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 4,827 ESSENTIO SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 3,592 PROPONENT DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 4,055 ALTRUA 2 DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 22,714 ESSENTIO DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.