Reported Jan 24, 2018 · Ongoing
ESSENTIO SR Pacemaker
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 Bldg 3 · Saint Paul, MN · 55112-5700
Is this the product you have?
- ESSENTIO SR Pacemaker
- Lot codes and dates
- Model L100
- Amount recalled
- N/A
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
Why it was recalled
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
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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