Reported Apr 28, 2021 · Terminated
BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - 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 7VR-T DX DF-1REF 393037
- UDI04035479129521 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
386 of 386 codes
608193096081931260819314608193166081931760819332608193336081961460819616608196366081963860819640608196426081964360819646608196496081965260819655608196676081968260819948608199496081995460819955608199576081996460819966608199676082068260820684608206876082069060820701608207026082070460820705608207086082070960820716608207176082072060820724608207256082072660821168608211706082117160821174608211836082118460821185608211916082119360821199608212066082120760821209608212126082225260822253
- Serial Number
- Amount recalled
- 386 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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