Reported Apr 28, 2021 · Terminated
BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - 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 Iforia 7DR-TDF-1REF 390064
- UDI04035479126926 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
489 of 489 codes
607178606072297460725417607257536072685760726883607269106072719360727205607272156072722560727234607272536072740860727417607280426072804760728050607288046072880960728810607288116072881360728825607288526072885460728857607288656072888860728913607289156072893660728989607289986072901960729022607290476072904960729051607290566072906560729068607290846072908760729120607291226072980460730307607303216073032560730333607303376073035660730599607306236073139260731401607314226073802760738986
- Serial Number
- Amount recalled
- 490 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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