Reported Apr 28, 2021 · Terminated
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - 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 7VR-T DF4 ProMRIREF 404626
- UDI04035479142131 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
779 of 779 codes
609215146092155560922407609224106092242260922436609224386092243960922791609227926092279360923703609237246092374060925141609251696092517360925178609251846092549960927059609270666092707560927476609274786092747960927481609274916092749460927499609287216092872360928725609287266092872860928730609287736092878060928852609302776093027960930281609302846093028860930294609303006093030160930304609303056093031060930313609303146093031960930326609317026093170560931709609317106093171160931712
- Serial Number
- Amount recalled
- 779 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.
Want the full recall guide?
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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