Reported Apr 28, 2021 · Terminated
BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - 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 INVENTRA 7VR-T DX DF-1REF 399437
- UDI04035479136321 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
285 of 285 codes
607812736078234560782367607823686078237060782375607842956079540160795403607954076079541360799707607997096079971060799711607997126079971560799720607997216079972360799725607997266079972760799728607997296079973060799731607997326079973360799734607997376079973860799740607997426079974360799744607997466079974760799748607997506079975260799753607997546079975560801025608010266080102960801031608010326080103460801035608010366080103860801039608010416080104260801043608010446080819360808204
- Serial Number
- Amount recalled
- 285 Unit
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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