Reported Apr 28, 2021 · Terminated
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - 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 INVENTRA 7HF-T QP DF4 IS4REF 393012
- UDI04035479129286 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
702 of 702 codes
608412866086929660870124608701256087012760870130608701316087013260870136608701406087014160870142608701436087330760873308608733096087331060873311608733146087331560873316608733176087331960873320608733216087332260873323608733246087332560873326608751706087517160875172608751736087517460875175608751766087517760875178608751796087881060878815608788166087881760878818608788196087882160878822608788236087882460878825608788266087882860878829608788306087883160878832608788336087883460878837
- Serial Number
- Amount recalled
- 702 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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