Reported Apr 28, 2021 · Terminated
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - 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 DR-TDF-4REF383564
- UDI04035479125202 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Affected Serial Number
862 of 862 codes
607445856074458660744588607445896074459060744591607445926074459360744594607445956074459660744597607445986074459960744600607446026074460360744605607446066074460760744609607446106074461160744612607446136074461460744735607447366074473960744740607447416074474260744744607447466074474760744748607447496074475160744752607447536074567560745676607456786074567960745680607456816074568260745895607458966074589760745898607458996074590060745901607459026074590360745905607459066074590760745912
- Affected Serial Number
- Amount recalled
- N/A
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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