Reported Apr 28, 2021 · Terminated
BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - 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 ITREVIA 7DR-T QP DF-1REF 392412
- UDI04035479128807 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
658 of 658 codes
608193156081931960819321608193246081932660819337608196096081961760819619608196256081962660819637608196396081965960819677608196806081968360819684608206836082068960820691608206926082069660820698608207006082070360820706608207216082116660821204608238636082646960826472608264786082648260826489608266566082666360826708608267306082689760829520608295336082957360829578608295796083161160831613608316166083162860831629608316316083163460831636608318776083192260832196608331116083312160833124
- Serial Number
- Amount recalled
- 658 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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