Reported Apr 28, 2021 · Terminated
BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - 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 Iforia 7vr-TDXDF-1REF 390090
- UDI04035479127176 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
1,176 of 1,176 codes
607249526072562660726518607265216072688460726900607271956072721660727250607273846072739260727796607280406072805260728058607287996072880060728805607288076072882260728826607288276072882860728837607288476072885860728881607289146072892060728938607290026072900560729018607290406072904860729055607290586072907960729086607291276072978960729791607297936072979760729803607298076072980860729816607303096073031160730313607303166073031960730330607303356073035760731398607314006073141460731415
- Serial Number
- Amount recalled
- 1176 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.
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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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