FDA (Devices) recall action 86866
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Accelerated battery depletion may result in a need for device replacement earlier than expected.
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 11,296 Emblem MRI S-ICD pulse generators because accelerated battery depletion may require earlier device replacement.
Boston Scientific is recalling 7,093 Emblem S-ICD pulse generators because accelerated battery depletion may require earlier device replacement.