Reported Apr 28, 2021 · Terminated
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - 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 VR-TDF-1REF 383578
- UDI04035479125349 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
1,000 of 1,000 codes
607133566071335760713358607133596071336060713361607133626071336360713364607133656071528260715285607152866071528760715288607152926071529360715296607152996071530060715301607161936071619460716195607161966071619760716198607161996071620160716203607162046071620560716208607162106071659760716598607165996071660060716603607166046071660660716608607166116071661260716613607166156071661660716647607166486071665160716652607166536071665460716655607166566071798260717984607179856071798860717989
- Serial Number
- Amount recalled
- 1000 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.
Want the full recall guide?
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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