Reported Apr 28, 2021 · Terminated
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - 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 DF-1REF 393040
- UDI04035479129552 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
499 of 499 codes
607972206079722160797222607972236079722460797225607972266079722760797228607972306079723360797234607972356079723660797238607972396079724060797244607972456079875560798756607987576079875960798762607987646079876560798767607987706079877360798774607987756079877660798777607987806079878560798786607987926079879360798794608006036080060460800605608006076080061360800615608006186080073160800733608007366080073760800738608007406080074260800743608007446080074560800746608007786080078260800784
- Serial Number
- Amount recalled
- 499 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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