Reported Apr 28, 2021 · Terminated
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - 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-1REF383562
- UDI04035479125189 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- serial numbers
2,557 of 2,557 codes
607053176070797760708912607091576070939360709408607099926071000260710004607100066071000960710010607102026071020360711081607110936071110860711123607111246071113060711285607112936071129760711301607116246071162860711633607116416071165360711655607116566071165860711659607116606071166160712136607121376071214260712164607121656071217160712212607123626071236460712366607123816071243360712434607124406071245360712454607124556071245660712632607126356071266260712667607126686071267760712678
- serial numbers
- 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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