Reported Feb 3, 2021 · Ongoing
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
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 MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
- Lot codes and dates
- Serial numbers
- distributed in the United States
4,069 of 4,069 codes
100371100467100485100548100591100641100705100710100717100742100745100791100866100868200019200023200031200043200049200067200125200126200127200128200129200152200157200161200163200167200170200171200176200181200182200185200186200187200190200191200192200195200198200214200217200224200228200232200236200239200241200244200247200251200256200258200261200262200264200266
- Amount recalled
- 11296 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.
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