FDA (Devices) recall action 78787
The FDA (Devices) publishes a recall like this one as 24 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 24 pages.
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
The agency’s own wording, quoted from the enforcement report.
Boston Scientific is recalling ACCOLADE DR pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling PROPONENT MRI Pacemakers because of reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ESSENTIO MRI EL DR Pacemakers because reports indicate the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling VALITUDE CRT-P pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ACCOLADE MRI EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ALTRUA 2 SR pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling PROPONENT SR Pacemakers because reports indicate the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ACCOLADE MRI DR Pacemakers because reports indicate the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling VISIONIST CRT-P pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ESSENTIO DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ACCOLADE MRI SR Pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ESSENTIO SR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ESSENTIO MRI SR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling VISIONIST X4 CRT-P Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ALTRUA 2 EL DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ACCOLADE SR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling PROPONENT DR Pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling PROPONENT EL DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ACCOLADE EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling VALITUDE X4 CRT-P pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ESSENTIO EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling certain pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ALTRUA 2 DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ESSENTIO MRI DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.