Reported Apr 28, 2021 · Terminated
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - 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 DR-T DF-1 ProMRIREF 429529
- UDI04035479156749 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
98 of 98 codes
610894308470322084724608847246228472462384724625847247868472479384724809847252918472531084725318847253328472534084725641847256558472574584725773847257748472578484725790847284818472977484729990847300008473009284730133847307238473074084730741847312278473146184731469847318388473184884731849847323398473235384732359847323608473258784732885847334968473375784734018847340278473404784734065847341068473558884735595847356088473637784736703847367058473673284736952847370298473703584737561
- Serial Number
- Amount recalled
- 98 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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