Reported Nov 15, 2017 · Terminated
RESONATE X4 CRT-D, Model G447, 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 X4 CRT-DModel G447Sterile
- Lot codes and dates
Serial numbers 174030174900174995175178175328175329175396175440175503175545and 175606
- Amount recalled
- 11 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.
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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