FDA (Devices) recall action 81001
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
The agency’s own wording, quoted from the enforcement report.
Boston Scientific is recalling ESSENTIO pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.
Boston Scientific is recalling VALITUDE X4 CRT-P pacemakers because hydrogen-induced accelerated battery depletion may require early replacement.
Boston Scientific is recalling PROPONENT pacemakers because hydrogen exposure may cause the battery to deplete faster than expected, requiring early replacement.
Boston Scientific is recalling specific ACCOLADE pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.
Boston Scientific is recalling VISIONIST X4 CRT-P pacemakers because hydrogen-induced accelerated battery depletion may require early replacement.