Reported Apr 28, 2021 · Terminated
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular…
BIOTRONIK Inc.
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: BIOTRONIK Inc · 6024 Jean Rd · Lake Oswego, OR · 97035-5571
Is this the product you have?
BIOTRONIK ITREVIA 7VR-T DF-4REF 393041
- UDI04035479129569 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
670 of 670 codes
607588736079050760790508607905096079310060793104607931126079311360793114607931156079312060793132607931516079344660793447607978076079781060797811607978136079781860797820607978246079782560797829607978326079783360797835607978386079784060797841607978426079785360797854607978566079861760798618607986206079863360798637607986416079991060799917607999216079992460799925607999266079992960799935607999376079993860799947608009966080099860802135608021416080214460802568608025756080257960805453
- Serial Number
- Amount recalled
- 670 units
This recall covers 25 products
The agency filed one notice per product. You are reading one of them; the other 24 are below.
12 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
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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