Reported Apr 28, 2021 · Terminated
BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide…
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 NEO 7 VR-T DF-1 ProMRIREF 429531
- UDI04035479156763 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
74 of 74 codes
610915088470294384730466847304678473047384731681847320418473317184733182847331848473356684733567847335738473357684733579847335848473378984733797847340878473409384734876847348778473563484735637847356398473564284737565847375728473757884737923847382808473828184738284847386178473862084738621847390428473904984739285847392888474002784740029847405298474098184741287847413008474130184741302847414238474155884741561847417398474188384741898847422568474226184743460847434638474390884743932
- Serial Number
- Amount recalled
- 74 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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