FDA (Devices) recall action 88087
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
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 VALITUDE CRT-P pacemakers (models U125 and U128) may experience hydrogen release that compromises the capacitor, causing accelerated battery depletion. Patients should consult their healthcare provider.
Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.
Boston Scientific has recalled certain Proponent pacemaker models worldwide. Hydrogen gas may accumulate inside the device, compromising the capacitor and causing accelerated battery depletion.
Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.
Boston Scientific is recalling six Essentio pacemaker models due to a hydrogen release defect that may compromise a critical capacitor and cause accelerated battery depletion. Approximately 31,548 units worldwide are affected.
Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.