Reported Apr 28, 2021 · Terminated
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - 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 Ilestro 7 VR-TDF-4REF 383580
- UDI04035479125363 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
323 of 323 codes
607573566076036360760397607616286076163160761650607616616076166460762689607626966076270660762707607627206076272360762729607627306076291560764027607640286076403060764031607640346076403760764038607640396076404160764042607640456076404760764049607640526076405460764179607641806076418160764183607659596076596060765962607659686076596960765972607659756076597860765980607659826076598360765985607659886076598960765990607659916076599360765996607672086076721060767212607672136076721460767217
- Serial Number
- Amount recalled
- 323 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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