Reported Jun 28, 2023 · Ongoing
ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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 DVMB2D4 EVERA MRI XT DF4 INTLModel Number DVMB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720565
- Lot Serial Numbers
1,038 of 1,038 codes
PLZ611718SPLZ611713SPLZ611719SPLZ613233SPLZ613240SPLZ613268SPLZ613269SPLZ613270SPLZ610634SPLZ612616SPLZ613234SPLZ610657SPLZ611892SPLZ610319SPLZ610320SPLZ610622SPLZ610625SPLZ610626SPLZ610627SPLZ610631SPLZ610670SPLZ610671SPLZ610672SPLZ610988SPLZ610990SPLZ610992SPLZ611154SPLZ611155SPLZ611159SPLZ611202SPLZ611643SPLZ611644SPLZ611645SPLZ611815SPLZ611819SPLZ611822SPLZ611889SPLZ611890SPLZ611891SPLZ610001SPLZ611744SPLZ610666SPLZ613301SPLZ613302SPLZ611722SPLZ611738SPLZ611741SPLZ611923SPLZ612176SPLZ613231SPLZ613236SPLZ613237SPLZ613250SPLZ613282SPLZ613288SPLZ613298SPLZ611726SPLZ611728SPLZ613246SPLZ613247S
- Lot Serial Numbers
1,673 of 1,673 codes
PLZ615098SPLZ612722SPLZ612725SPLZ612863SPLZ613047SPLZ613404SPLZ613574SPLZ613575SPLZ613783SPLZ613810SPLZ613828SPLZ614403SPLZ614561SPLZ614649SPLZ614824SPLZ614899SPLZ614912SPLZ614915SPLZ614916SPLZ614917SPLZ614969SPLZ615018SPLZ615019SPLZ615551SPLZ615632SPLZ615765SPLZ615801SPLZ610551SPLZ610599SPLZ610600SPLZ610604SPLZ610605SPLZ610606SPLZ610607SPLZ610695SPLZ610701SPLZ610703SPLZ611050SPLZ611051SPLZ611076SPLZ611078SPLZ611248SPLZ611249SPLZ611250SPLZ611252SPLZ611261SPLZ611268SPLZ611271SPLZ611272SPLZ611280SPLZ611308SPLZ611310SPLZ611311SPLZ611312SPLZ611316SPLZ611321SPLZ612462SPLZ612465SPLZ612466SPLZ612467S
- Amount recalled
- 6477 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.
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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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