Reported Jun 28, 2023 · Ongoing
ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; 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 DVBC3D1 EVERA S IS1/DF1 GLOBModel Number DVBC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720473
- Lot Serial Numbers
84 of 84 codes
BWM204909HBWM204998HBWM205011HBWM205017HBWM204963HBWM204962HBWM205000HBWM204927HBWM204911HBWM204921HBWM204926HBWM204932HBWM204936HBWM204944HBWM204954HBWM204955HBWM204959HBWM204983HBWM204984HBWM204989HBWM204990HBWM205004HBWM205006HBWM205008HBWM205013HBWM205014HBWM205015HBWM205016HBWM205019HBWM205021HBWM205023HBWM205024HBWM205027HBWM205033HBWM205036HBWM205037HBWM204792HBWM204938HBWM204961HBWM204916HBWM204922HBWM204950HBWM204957HBWM204993HBWM205009HBWM204923HBWM204924HBWM204987HBWM205028HBWM204956HBWM204953HBWM204789HBWM204790HBWM204935HBWM204905HBWM204906HBWM204960HBWM204980HBWM204991HBWM204914H
- Lot Serial Numbers
1,954 of 1,954 codes
BWM606690SBWM606723SBWM608186SBWM607102SBWM606494SBWM607083SBWM606927SBWM607005SBWM607272SBWM606644SBWM606971SBWM607093SBWM606920SBWM606879SBWM606579SBWM606943SBWM607045SBWM607027SBWM606500SBWM606861SBWM606975SBWM607158SBWM606473SBWM608141SBWM606616SBWM606706SBWM606946SBWM607013SBWM606719SBWM606720SBWM607007SBWM607154SBWM607170SBWM607176SBWM608142SBWM608146SBWM608951SBWM606685SBWM606728SBWM606911SBWM606921SBWM606930SBWM606931SBWM606932SBWM606986SBWM607014SBWM607407SBWM606903SBWM607018SBWM606681SBWM606907SBWM607024SBWM606178SBWM606475SBWM606478SBWM606852SBWM606853SBWM607114SBWM607119SBWM606686S
- Lot Serial Numbers
670 of 670 codes
BWM612848SBWM612852SBWM609327SBWM607837SBWM608082SBWM607702SBWM607334SBWM607816SBWM607198SBWM608330SBWM607562SBWM608007SBWM608295SBWM608383SBWM608334SBWM607287SBWM607618SBWM607629SBWM607996SBWM609218SBWM607340SBWM607342SBWM608292SBWM611257SBWM608000SBWM608373SBWM607333SBWM607496SBWM609220SBWM607523SBWM607615SBWM607810SBWM609201SBWM607805SBWM608290SBWM607833SBWM611419SBWM607199SBWM607208SBWM607279SBWM607241SBWM607555SBWM611587SBWM609810SBWM607551SBWM607732SBWM607994SBWM610739SBWM607221SBWM607617SBWM607636SBWM607990SBWM608054SBWM610647SBWM607978SBWM609356SBWM607341SBWM607206SBWM607710SBWM607556S
- Amount recalled
- 6821 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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