Reported Jun 28, 2023 · Ongoing
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
ICD-VR DVBC3D4 EVERA S DF4 GLOBModel Number DVBC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720442
- Lot Serial Numbers
61 of 61 codes
BWL206052HBWL205879HBWL206062HBWL206106HBWL206057HBWL206066HBWL206087HBWL205882HBWL206049HBWL206050HBWL206053HBWL206055HBWL206059HBWL206069HBWL206073HBWL206074HBWL206078HBWL206079HBWL206081HBWL206082HBWL206083HBWL206084HBWL206101HBWL206104HBWL206110HBWL206112HBWL206116HBWL206118HBWL206120HBWL206122HBWL206123HBWL206126HBWL206127HBWL206068HBWL206071HBWL206092HBWL206093HBWL206094HBWL206109HBWL206117HBWL206119HBWL206097HBWL205878HBWL206098HBWL206063HBWL206114HBWL206108HBWL206048HBWL206064HBWL206058HBWL206086HBWL206099HBWL206076HBWL206103HBWL206107HBWL206124HBWL206125HBWL206105HBWL206051HBWL206054H
- Lot Serial Numbers
2,246 of 2,246 codes
BWL606762SBWL606799SBWL609508SBWL606741SBWL607597SBWL607510SBWL607234SBWL606748SBWL607162SBWL607513SBWL607947SBWL606791SBWL607876SBWL606995SBWL607071SBWL606857SBWL606752SBWL607088SBWL606806SBWL606900SBWL606908SBWL606738SBWL606758SBWL606759SBWL607084SBWL607199SBWL607220SBWL607277SBWL607512SBWL607519SBWL607558SBWL607571SBWL607805SBWL607806SBWL609503SBWL609505SBWL609506SBWL606452SBWL606742SBWL606743SBWL606751SBWL606757SBWL606766SBWL606767SBWL606805SBWL606840SBWL606899SBWL606942SBWL607001SBWL607013SBWL607074SBWL607215SBWL607423SBWL607542SBWL607590SBWL607593SBWL607594SBWL607613SBWL607716SBWL607910S
- Lot Serial Numbers
401 of 401 codes
BWL608258SBWL608296SBWL607988SBWL608287SBWL608293SBWL608609SBWL608859SBWL608335SBWL608327SBWL608068SBWL608002SBWL611277SBWL608776SBWL608080SBWL610179SBWL607922SBWL607987SBWL608329SBWL608001SBWL608006SBWL608016SBWL608264SBWL608430SBWL608426SBWL608458SBWL608459SBWL608460SBWL608462SBWL608463SBWL608546SBWL608565SBWL608610SBWL608611SBWL607926SBWL607982SBWL608073SBWL609960SBWL609962SBWL609973SBWL607917SBWL607919SBWL607920SBWL607927SBWL607934SBWL607977SBWL607980SBWL608078SBWL608311SBWL608420SBWL608558SBWL607924SBWL607925SBWL608074SBWL608075SBWL608134SBWL608135SBWL608279SBWL608283SBWL608544SBWL608545S
- Amount recalled
- 5296 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Using this product could cause serious injury, illness or death — stop using it now.
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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