Reported Apr 28, 2021 · Terminated
BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - 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 ILIVIA 7DR-T DF-1 PROMRIREF 404622
- UDI04035479142094 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
1,547 of 1,547 codes
610097456103104161031948610354656103547761036566610371186103735261037354610373676103737161037377610373836103738461037386610373936103794061037953610379666103866461038665610386726103867961038700610387016103870561038709610387106103871161038715610387206103872261038731610387326103890561038929610391386103937661039377610393816103938461039385610393886103939361040798610409536104096661040978610409886104099261041010610414056104140761041495610415006104150961041543610415606104156961041572
- Serial Number
- Amount recalled
- 1547 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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