Reported Apr 28, 2021 · Terminated
BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - 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 Iperia 7DR-TDF-1ProMRI REF 392409
- UDI04035479128777 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
1,652 of 1,652 codes
608244746082447560824491608246296082464260824679608250026082501360825017608250226082502360825049608250556082569960825703608257096082571760825726608257296082573460825740608259016082590660825926608259456082650160826504608266526082666060826693608266996082671660826726608267356083189060833123608337026083413660834474608345126083452560834535608348696083562960835640608356506083565760835662608356646083566860835978608359986083621860837185608371936083721360837218608372336083742260837427
- Serial Number
- Amount recalled
- 1652 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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