Reported Nov 15, 2017 · Terminated
RESONATE EL ICD VR, Model D432, Sterile.
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 · Saint Paul, MN · 55112-5700
Is this the product you have?
- RESONATE EL ICD VR, Model D432, Sterile.
- Lot codes and dates
Serial numbers 224020224209224322224366and 224506
- Amount recalled
- 5 devices
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The devices have an incorrect firmware configuration.
This product could cause temporary or reversible health problems — stop using it.
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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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