Reported Nov 9, 2022 · Ongoing
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, 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 MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
- Lot codes and dates
- UPN00802526584404
- Serial numbers
77 of 77 codes
169280169298169494169753169776169934169941170003169547169151169315169514169851169879169292169696169786169788169852170002169400169405169898169973169885169335169233169608169304169410166452169278169319169321169651169688169864169920169235169277169834169472169417169202169329169426169511169529169630169757169963167092169236169301169310169316169393169436169485169537
- UPN
66 of 66 codes
00802526581519Serial numbers 169312169409169421169428169521169561169493169654169653169635169731169477169495169496169474169491169468169455169442169446169435169447168979169271169384169353169371169351169203169469169471169314169342169475169448169404169407169450169396169470169356169373169402169413169441169539169545169551169674169267169350169589169307169595169596169600169286169603169605
- Amount recalled
- 142 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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