FDA-Device2017-11-15Class II
RESONATE EL ICD DR, Model D433, Sterile.
Hazard
The devices have an incorrect firmware configuration.
Sold states
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Affected count
12 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
RESONATE EL ICD DR, Model D433, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2018More Boston Scientific Corporation recalls
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- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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