Reported Jun 28, 2023 · Ongoing
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; 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 DVME3D1 MIRRO MRIModel Number DVME3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001605
- Lot Serial Numbers
2,714 of 2,714 codes
CWP603713SCWP601986SCWP600810SCWP602954SCWP602169SCWP602564SCWP602486SCWP601838SCWP600696SCWP602627SCWP602315SCWP602621SCWP604004SCWP603407SCWP603894SCWP604066SCWP602233SCWP603772SCWP603201SCWP603888SCWP602797SCWP603582SCWP603254SCWP603475SCWP602907SCWP603605SCWP603606SCWP602148SCWP602999SCWP601940SCWP602860SCWP600692SCWP600693SCWP601684SCWP601750SCWP602026SCWP602250SCWP602395SCWP600661SCWP600672SCWP600673SCWP601025SCWP601261SCWP601303SCWP601404SCWP601545SCWP601730SCWP601740SCWP601753SCWP601912SCWP602158SCWP602213SCWP602504SCWP602670SCWP603190SCWP603321SCWP603588SCWP601814SCWP603269SCWP600319S
- Amount recalled
- 3852 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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