Reported Jun 28, 2023 · Ongoing
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; 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-DR DDME3D1 MIRRO MRIModel Number DDME3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001568
- Lot Serial Numbers
2,714 of 2,714 codes
CWS603181SCWS601328SCWS601620SCWS601980SCWS602302SCWS602482SCWS602880SCWS602742SCWS602559SCWS602607SCWS602433SCWS602957SCWS601056SCWS601348SCWS601807SCWS602219SCWS602422SCWS602474SCWS601519SCWS601425SCWS601296SCWS602918SCWS600483SCWS600490SCWS600494SCWS600607SCWS600960SCWS601001SCWS601199SCWS601460SCWS601594SCWS601704SCWS601713SCWS601790SCWS600422SCWS600502SCWS600125SCWS600132SCWS600342SCWS600571SCWS601791SCWS600172SCWS600318SCWS600423SCWS600453SCWS600464SCWS600686SCWS601122SCWS601155SCWS601445SCWS601981SCWS601465SCWS601628SCWS600445SCWS602676SCWS600945SCWS600142SCWS600147SCWS600178SCWS600551S
- Amount recalled
- 2831 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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