Reported Apr 28, 2021 · Terminated
BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - 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 INVENTRA 7VR-T DX DF-1 ProMRIREF 399436
- UDI04035479136314 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
3,259 of 3,259 codes
609343516082915260832096608323716083237960832390608324026083241360832416608327416083274860832754608327616083276360832880608328896083291060832928608344126083443560836055608360636083760260839079608390926083909760851001608525196085252760853576608535806085450160855490608554956085549960857084608570856085708660857087608571036085771060857718608577216085778960858453608584576085846060858466608584686085847260858477608584806085848160858483608593706085937260859378608593806085938860859392
- Serial Number
- Amount recalled
- N/A
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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