Reported Apr 28, 2021 · Terminated
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - 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 DF-1 ProMRIREF 404625
- UDI04035479142124 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
914 of 914 codes
609216416092164560921650609216546092166160921676609216816092448760924853609254636092546660925467609254696092547260927681609296766092968160929693609307256093072760930729609307306093182260931823609318276093182860931832609318436093184860931851609327936093279660932825609328336093283560934488609345036093588360937416609374316093744460937446609374486093745560937459609374616093746360938681609386826094031360940320609403266094033560940914609431176094436960944385609443886094439060946404
- Serial Number
- Amount recalled
- 914 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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