Reported Nov 9, 2022 · Ongoing
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, 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?
- EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
- Lot codes and dates
- UPN
00802526548406Serial numbers 169276169509169645169774169876169671169297
- UPN
- Amount recalled
- 7 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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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