Reported Feb 17, 2021 · Terminated
EMBLEM MRI S-ICD Model A219
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 MRI S-ICD Model A219
- Lot codes and dates
- Serial numbers
872 of 872 codes
100641200266200291200317200347200348200359200368200369200375200378200431200479200481200631200762200786200787200818200821200822200838200848200854200874200888200889200896200899200905200910200914200919200925200927200965200966200979200986200990200991200992200995200996200997201012201016201021201024201031201036201044201050201103201131201133201135201137201157201172
- Serial numbers
- Amount recalled
- 872 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
Stop using this product now
Electrical overstress may lead to device malfunction.
Using this product could cause serious injury, illness or death — stop using it now.
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.
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