Reported Feb 3, 2021 · Ongoing
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N Bldg 3 · Saint Paul, MN · 55112-5700
Is this the product you have?
- EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
- Lot codes and dates
- Serial numbers distributed in the US
4,070 of 4,070 codes
101624101701101757101808101835101845101869101878101946101953101957101958101960102009102048102055102060102061102074102079102081102096102120102129102177102178102183102190102194102195102196102205102220102239102251102272102277102307102319102334102383102384102403102406102409102416102418102426102428102432102438102441102452102473102491102495102505102522102535102536
- Serial numbers distributed in the US
- Amount recalled
- 7093 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Accelerated battery depletion may result in a need for device replacement earlier than expected.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.