Reported Jun 28, 2023 · Ongoing
ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; 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 VISIA MRI AF XT OUS DF4Model Number DVFB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169717992
- Lot Serial Numbers
479 of 479 codes
PLX607314SPLX608121SPLX612778SPLX613087SPLX604547SPLX610926SPLX606361SPLX608125SPLX610724SPLX610983SPLX609285SPLX608127SPLX608938SPLX610866SPLX612123SPLX608086SPLX608118SPLX609410SPLX610864SPLX610961SPLX610967SPLX611934SPLX611951SPLX614024SPLX614073SPLX608054SPLX605322SPLX614114SPLX607228SPLX607330SPLX607943SPLX613085SPLX609803SPLX607928SPLX605323SPLX607310SPLX607333SPLX606750SPLX608915SPLX608983SPLX609494SPLX610736SPLX610740SPLX610953SPLX610949SPLX612097SPLX608914SPLX607332SPLX607785SPLX607788SPLX609693SPLX609858SPLX608510SPLX607200SPLX610731SPLX606698SPLX607506SPLX610276SPLX606134SPLX605235S
- Lot Serial numbers
2,232 of 2,232 codes
PLX612879SPLX613648SPLX614366SPLX612156SPLX607872SPLX611977SPLX615851SPLX613825SPLX615377SPLX614963SPLX610427SPLX616168SPLX604202SPLX604618SPLX605160SPLX605368SPLX605485SPLX605489SPLX605493SPLX605584SPLX605922SPLX605944SPLX606024SPLX606930SPLX607094SPLX607537SPLX607599SPLX607953SPLX608085SPLX608145SPLX609262SPLX609264SPLX609562SPLX610795SPLX612528SPLX612529SPLX612601SPLX612888SPLX613321SPLX615065SPLX616025SPLX616484SPLX604539SPLX610755SPLX610756SPLX611836SPLX611839SPLX611845SPLX612013SPLX607702SPLX614047SPLX611036SPLX612868SPLX606452SPLX612263SPLX606059SPLX605046SPLX607701SPLX606056SPLX609414S
- Amount recalled
- 15381 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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